TUBE TRACHEOSTOMY AND TUBE CUFF
This device is manufactured by COVIDIEN.
The following problems were reported about this device:
Date | Event Type | Patient Problem | Device Problem |
---|---|---|---|
2024-06-27 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
2024-06-27 | Malfunction | Unintended Extubation | None |
2024-06-01 | Injury | Hypoventilation, Unintended Extubation | Gas/Air Leak |
2024-05-07 | Malfunction | No Clinical Signs, Symptoms or Conditions | Use of Device Problem |
2024-05-07 | Malfunction | No Clinical Signs, Symptoms or Conditions | Use of Device Problem |
2024-05-07 | Malfunction | No Clinical Signs, Symptoms or Conditions | Use of Device Problem |
2024-03-31 | Malfunction | No Clinical Signs, Symptoms or Conditions | Use of Device Problem |
2024-03-21 | Malfunction | No Clinical Signs, Symptoms or Conditions | Use of Device Problem |
2024-03-20 | Malfunction | Insufficient Information | Gas/Air Leak |
2024-03-05 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
2024-02-19 | Malfunction | No Clinical Signs, Symptoms or Conditions | Gas/Air Leak, Material Split, Cut or Torn |
2024-02-13 | Malfunction | Unintended Extubation | Gas/Air Leak |
2024-02-01 | Death | Unintended Extubation, Insufficient Information | Disconnection, Human-Device Interface Problem |
2024-01-22 | Malfunction | No Clinical Signs, Symptoms or Conditions | Use of Device Problem |
2024-01-15 | Malfunction | No Clinical Signs, Symptoms or Conditions | Use of Device Problem |
2023-12-26 | Malfunction | No Clinical Signs, Symptoms or Conditions | Use of Device Problem |
2023-12-22 | Malfunction | No Clinical Signs, Symptoms or Conditions | Defective Component |
2023-12-11 | Malfunction | No Clinical Signs, Symptoms or Conditions | Use of Device Problem |
2023-12-11 | Malfunction | No Clinical Signs, Symptoms or Conditions | Use of Device Problem |
2023-12-06 | Malfunction | Unintended Extubation | None |
2023-11-01 | Malfunction | Unintended Extubation | Gas/Air Leak |
2023-09-27 | Malfunction | No Clinical Signs, Symptoms or Conditions | Connection Problem |
2023-09-25 | Malfunction | No Clinical Signs, Symptoms or Conditions | Use of Device Problem |
2023-09-25 | Malfunction | No Clinical Signs, Symptoms or Conditions | Gas/Air Leak |
2023-09-01 | Malfunction | Insufficient Information | Connection Problem |
2023-08-03 | Malfunction | No Clinical Signs, Symptoms or Conditions | Use of Device Problem, Material Split, Cut or Torn |
2023-06-30 | Malfunction | Insufficient Information | Material Split, Cut or Torn |
2023-06-20 | Malfunction | Unintended Extubation | Gas/Air Leak |
2023-06-18 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Split, Cut or Torn |
2023-04-28 | Malfunction | Unintended Extubation, No Clinical Signs, Symptoms or Conditions | Use of Device Problem |
2023-04-14 | Malfunction | No Clinical Signs, Symptoms or Conditions | Obstruction of Flow, Appropriate Term/Code Not Available |
2023-03-13 | Malfunction | No Clinical Signs, Symptoms or Conditions | Use of Device Problem |
2023-02-21 | Malfunction | Unintended Extubation | Material Split, Cut or Torn |
2023-01-13 | Malfunction | None | Material Discolored, No Apparent Adverse Event |
2022-11-10 | Malfunction | None | Defective Component, Gas/Air Leak |
2022-11-10 | Injury | None | Gas/Air Leak |
2022-11-10 | Injury | None | Gas/Air Leak |
2022-10-25 | Malfunction | None | Gas/Air Leak |
2022-10-14 | Malfunction | None | Use of Device Problem |
2022-10-14 | Injury | None | Gas/Air Leak |
2022-10-05 | Malfunction | None | Use of Device Problem |
2022-09-30 | Malfunction | None | Defective Component |
2022-09-30 | Malfunction | None | Defective Component |
2022-09-30 | Malfunction | None | Defective Component |
2022-09-30 | Malfunction | None | Defective Component |
2022-09-30 | Malfunction | None | Defective Component |
2022-09-30 | Malfunction | None | Defective Component |
2022-09-30 | Malfunction | None | Defective Component |
2022-09-30 | Malfunction | None | Defective Component |
2022-09-30 | Malfunction | None | Defective Component |
2022-08-19 | Malfunction | None | Use of Device Problem |
2022-08-18 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Split, Cut or Torn |
2022-07-04 | Malfunction | None | Use of Device Problem |
2022-03-28 | Malfunction | None | Gas/Air Leak |
2022-03-23 | Malfunction | None | Manufacturing, Packaging or Shipping Problem |
2022-03-11 | Malfunction | None | Use of Device Problem |
2020-12-18 | Injury | None | Contamination of Device Ingredient or Reagent |
2019-08-30 | Malfunction | None | Use of Device Problem |
2019-08-29 | Injury | None | Defective Component |
2019-08-29 | Injury | None | Use of Device Problem |
2019-08-23 | Malfunction | None | Use of Device Problem, Material Split, Cut or Torn |
2019-08-23 | Malfunction | None | Use of Device Problem, Material Split, Cut or Torn |
2019-08-23 | Malfunction | None | Material Separation |
2019-08-22 | Malfunction | None | Material Split, Cut or Torn |
2019-08-21 | Malfunction | None | Use of Device Problem |
2019-08-14 | Malfunction | None | Material Separation |
2019-08-14 | Malfunction | None | Material Separation |
2019-08-13 | Injury | None | Appropriate Term/Code Not Available |
2019-08-12 | Malfunction | None | Use of Device Problem |
2019-08-09 | Injury | None | Appropriate Term/Code Not Available |
2019-08-07 | Malfunction | None | Gas/Air Leak |
2019-08-07 | Malfunction | None | Gas/Air Leak |
2019-07-31 | Malfunction | None | Material Split, Cut or Torn |
2019-07-18 | Malfunction | None | Use of Device Problem |
2019-07-17 | Injury | None | Appropriate Term/Code Not Available |
2019-07-15 | Malfunction | None | Use of Device Problem |
2019-07-15 | Malfunction | None | Obstruction of Flow |
2019-07-07 | Injury | None | Defective Component |
2019-06-11 | Injury | None | Material Separation |
2019-06-10 | Malfunction | None | Unintended Movement |
2019-05-27 | Malfunction | None | Inflation Problem |
2019-05-18 | Malfunction | None | Filling Problem, Leak/Splash |
2019-05-16 | Injury | None | Inflation Problem |
2019-05-15 | Malfunction | None | Leak/Splash |
2019-05-06 | Injury | None | Contamination of Device Ingredient or Reagent, Human-Device Interface Problem |
2019-05-06 | Injury | None | Contamination of Device Ingredient or Reagent, Human-Device Interface Problem |
2019-05-01 | Injury | None | Use of Device Problem |
2019-05-01 | Death | None | Use of Device Problem |
2019-04-18 | Malfunction | None | Partial Blockage |
2019-04-15 | Injury | None | Leak/Splash |
2019-04-11 | Injury | None | Appropriate Term/Code Not Available |
2019-03-29 | Malfunction | None | Component Missing |
2019-03-27 | Malfunction | None | Inflation Problem |
2019-03-25 | Malfunction | None | Material Split, Cut or Torn |
2019-03-25 | Malfunction | None | Material Split, Cut or Torn |
2019-03-22 | Injury | None | False Alarm |
2019-03-18 | Malfunction | None | Material Rupture |
2019-03-12 | Malfunction | None | Partial Blockage |
2019-03-04 | Malfunction | None | Break |
2019-02-11 | Malfunction | None | Inflation Problem |
2019-02-03 | Injury | None | Leak/Splash |
2019-01-21 | Injury | None | Obstruction of Flow |
2019-01-10 | Injury | None | Burst Container or Vessel |
2019-01-10 | Malfunction | None | Leak/Splash |
2019-01-10 | Malfunction | None | Burst Container or Vessel |
2019-01-08 | Injury | None | Burst Container or Vessel |
2019-01-03 | Injury | None | Inflation Problem |
2018-12-21 | Injury | None | Device Operates Differently Than Expected |
2018-12-21 | Malfunction | None | Device Packaging Compromised |
2018-12-21 | Malfunction | None | Inflation Problem |
2018-12-20 | Malfunction | None | Human-Device Interface Problem |
2018-12-17 | Malfunction | None | Material Deformation |
2018-12-06 | Injury | None | Leak/Splash, Gas/Air Leak |
2018-11-30 | Malfunction | None | Inflation Problem |
2018-11-29 | Malfunction | None | Material Integrity Problem |
2018-11-12 | Injury | None | Human-Device Interface Problem |
2018-11-01 | Malfunction | None | Leak/Splash, Gas/Air Leak |
2018-10-30 | Injury | None | Human-Device Interface Problem |
2018-10-10 | Malfunction | None | Component Missing |
2018-10-09 | Malfunction | None | Inflation Problem |
2018-10-05 | Injury | None | Air Leak |
2018-10-03 | Injury | None | Occlusion Within Device |
2018-09-27 | Malfunction | None | Break, Disconnection |
2018-09-21 | Injury | None | Inflation Problem |
2018-09-13 | Malfunction | None | Leak/Splash |
2018-09-06 | Malfunction | None | Inflation Problem |
2018-09-06 | Injury | None | Inflation Problem, Leak/Splash |
2018-09-01 | Malfunction | None | Defective Component |
2018-08-27 | Malfunction | None | Device Damaged Prior to Use |
2018-08-08 | Malfunction | None | Partial Blockage |
2018-08-06 | Malfunction | None | Break, Crack, Device Dislodged or Dislocated |
2018-07-26 | Malfunction | None | Device Damaged Prior to Use |
2018-07-10 | Malfunction | None | Adverse Event Without Identified Device or Use Problem, Material Split, Cut or Torn |
2018-06-29 | Malfunction | None | Break, Human-Device Interface Problem |
2018-06-22 | Malfunction | None | Component Missing |
2018-06-21 | Malfunction | None | Partial Blockage, Deflation Problem |
2018-06-15 | Injury | None | Improper or Incorrect Procedure or Method, Device Dislodged or Dislocated |
2018-06-15 | Malfunction | None | Partial Blockage |
2018-06-15 | Malfunction | None | Partial Blockage |
2018-06-15 | Malfunction | None | Partial Blockage |
2018-06-15 | Malfunction | None | Partial Blockage |
2018-06-12 | Injury | None | Air Leak, Partial Blockage |
2018-06-10 | Injury | None | Decrease in Pressure, Tidal Volume Fluctuations |
2018-05-25 | Malfunction | None | Manufacturing, Packaging or Shipping Problem |
2018-05-14 | Malfunction | None | Material Deformation |
2018-05-10 | Malfunction | None | Patient-Device Incompatibility |
2018-05-09 | Injury | None | Inflation Problem |
2018-04-09 | Malfunction | None | Break |
2018-03-29 | Malfunction | None | Split |
2018-03-27 | Malfunction | None | Partial Blockage |
2018-02-28 | Malfunction | None | Human-Device Interface Problem |
2018-02-16 | Injury | None | Air Leak |
2018-02-16 | Injury | None | Air Leak |
2018-02-10 | Injury | None | Inflation Problem |
2018-02-07 | Injury | None | Inflation Problem |
2018-02-06 | Malfunction | None | Deflation Problem |
2018-02-06 | Malfunction | None | Deflation Problem |
2018-02-06 | Malfunction | None | Inflation Problem |
2018-02-06 | Malfunction | None | Inflation Problem |
2018-02-05 | Injury | None | Material Separation |
2018-02-02 | Injury | None | Air Leak, Inflation Problem |
2018-02-01 | Malfunction | None | Inflation Problem |
2018-01-19 | Malfunction | None | Inflation Problem |
2018-01-12 | Malfunction | None | Leak/Splash |
2018-01-03 | Malfunction | None | Deflation Problem |
2018-01-03 | Malfunction | None | Deflation Problem |
2018-01-03 | Malfunction | None | Deflation Problem |
2017-12-20 | Malfunction | None | Air Leak |
2017-12-19 | Injury | None | Disconnection |
2017-12-16 | Malfunction | None | Deflation Problem |
2017-12-11 | Malfunction | None | Inflation Problem |
2017-12-05 | Malfunction | None | Partial Blockage, Deflation Problem |
2017-12-05 | Malfunction | None | Disconnection |
2017-12-05 | Malfunction | None | Crack |
2017-12-01 | Malfunction | None | Crack |
2017-11-28 | Malfunction | None | Deflation Problem |
2017-11-28 | Malfunction | None | Deflation Problem |
2017-11-28 | Malfunction | None | Deflation Problem |
2017-11-28 | Malfunction | None | Deflation Problem |
2017-11-28 | Malfunction | None | Deflation Problem |
2017-11-20 | Injury | None | Deflation Problem |
2017-11-15 | Malfunction | None | Inflation Problem |
2017-11-15 | Malfunction | None | Deflation Problem |
2017-11-13 | Injury | None | Deflation Problem |
2017-11-08 | Malfunction | None | Inflation Problem |
2017-11-06 | Malfunction | None | Deflation Problem |
2017-11-06 | Malfunction | None | Deflation Problem |
2017-11-03 | Injury | None | Disconnection, Stretched |
2017-11-02 | Injury | None | Detachment of Device or Device Component |
2017-11-02 | Injury | None | Disconnection |
2017-11-02 | Malfunction | None | Deflation Problem |
2017-11-02 | Malfunction | None | Deflation Problem |
2017-11-01 | Malfunction | None | Deflation Problem |
2017-11-01 | Malfunction | None | Deflation Problem |
2017-10-23 | Malfunction | None | Deflation Problem |
2017-10-23 | Malfunction | None | Deflation Problem |
2017-10-23 | Malfunction | None | Deflation Problem |
2017-10-19 | Malfunction | None | Inflation Problem |
2017-10-18 | Malfunction | None | Deflation Problem |
2017-10-12 | Malfunction | None | Deflation Problem |
2017-10-10 | Malfunction | None | Deflation Problem |
2017-10-10 | Malfunction | None | Deflation Problem |
2017-09-29 | Malfunction | None | Deflation Problem |
2017-09-29 | Malfunction | None | Deflation Problem |
2017-09-28 | Malfunction | None | Deflation Problem |
2017-09-28 | Malfunction | None | Deflation Problem, Inflation Problem |
2017-09-28 | Malfunction | None | Deflation Problem |
2017-09-28 | Malfunction | None | Deflation Problem |
2017-09-28 | Malfunction | None | Deflation Problem |
2017-09-28 | Malfunction | None | Deflation Problem |
2017-09-28 | Malfunction | None | Deflation Problem |
2017-09-22 | Malfunction | None | Manufacturing, Packaging or Shipping Problem |
2017-09-22 | Injury | None | Human-Device Interface Problem |
2017-09-22 | Injury | None | Human-Device Interface Problem |
2017-09-07 | Malfunction | None | Deflation Problem |
2017-09-07 | Malfunction | None | Air Leak, Occlusion Within Device |
2017-09-01 | Malfunction | None | Deflation Problem |
2017-08-25 | Malfunction | None | Deflation Problem |
2017-08-21 | Malfunction | None | Deflation Problem |
2017-08-17 | Malfunction | None | Deflation Problem |
2017-08-14 | Malfunction | None | Contamination |
2017-08-14 | Malfunction | None | Deflation Problem |
2017-08-14 | Malfunction | None | Contamination |
2017-08-14 | Malfunction | None | Contamination |
2017-08-04 | Malfunction | None | Deflation Problem |
2017-08-04 | Malfunction | None | Deflation Problem |
2017-08-04 | Malfunction | None | Deflation Problem |
2017-08-04 | Malfunction | None | Connection Problem |
2017-08-04 | Malfunction | None | Deflation Problem |
2017-08-04 | Malfunction | None | Deflation Problem |
2017-08-04 | Malfunction | None | Deflation Problem |
2017-08-04 | Malfunction | None | Deflation Problem |
2017-08-04 | Malfunction | None | Deflation Problem |
2017-08-04 | Malfunction | None | Deflation Problem |
2017-08-04 | Malfunction | None | Deflation Problem |
2017-08-04 | Malfunction | None | Deflation Problem |
2017-08-04 | Malfunction | None | Deflation Problem |
2017-08-04 | Malfunction | None | Deflation Problem |
2017-08-04 | Malfunction | None | Inflation Problem |
2017-08-02 | Malfunction | None | Inflation Problem |
2017-07-27 | Malfunction | None | Inflation Problem |
2017-07-27 | Malfunction | None | Inflation Problem |
2017-07-27 | Malfunction | None | Deflation Problem |
2017-07-20 | Injury | None | Inflation Problem |
2017-07-20 | Malfunction | None | Deflation Problem |
2017-07-18 | Malfunction | None | Deflation Problem |
2017-07-18 | Malfunction | None | Deflation Problem |
2017-07-05 | Malfunction | None | Material Integrity Problem |
2017-07-03 | Malfunction | None | Deflation Problem |
2017-07-03 | Malfunction | None | Deflation Problem |
2017-06-28 | Malfunction | None | Inflation Problem |
2017-06-21 | Malfunction | None | Deflation Problem |
2017-06-19 | Malfunction | None | Manufacturing, Packaging or Shipping Problem |
2017-06-16 | Malfunction | None | Deflation Problem |
2017-06-12 | Injury | None | Inflation Problem |
2017-06-06 | Injury | None | Deflation Problem |
2017-06-05 | Injury | None | Human-Device Interface Problem |
2017-06-05 | Malfunction | None | Inflation Problem |
2017-06-01 | Malfunction | None | Deflation Problem |
2017-06-01 | Malfunction | None | Deflation Problem |
2017-06-01 | Malfunction | None | Deflation Problem |
2017-05-30 | Injury | None | Suction Problem, Obstruction of Flow |
2017-05-30 | Malfunction | None | Deflation Problem |
2017-05-30 | Injury | None | Deflation Problem |
2017-05-29 | Malfunction | None | Inflation Problem |
2017-05-29 | Malfunction | None | Break, Detachment Of Device Component, Device Displays Incorrect Message |
2017-05-26 | Injury | None | Inflation Problem |
2017-05-24 | Malfunction | None | Deflation Problem |
2017-05-23 | Malfunction | None | Deflation Problem |
2017-05-12 | Malfunction | None | Deflation Problem |
2017-05-12 | Malfunction | None | Deflation Problem |
2017-05-10 | Injury | None | Air Leak |
2017-04-26 | Malfunction | None | Deflation Problem |
2017-04-26 | Malfunction | None | Deflation Problem |
2017-04-26 | Malfunction | None | Deflation Problem |
2017-04-26 | Malfunction | None | Deflation Problem |
2017-04-26 | Malfunction | None | Deflation Problem |
2017-04-26 | Malfunction | None | Deflation Problem |
2017-04-26 | Malfunction | None | Deflation Problem |
2017-04-26 | Malfunction | None | Deflation Problem |
2017-04-26 | Malfunction | None | Deflation Problem |
2017-04-26 | Malfunction | None | Deflation Problem |
2017-04-26 | Malfunction | None | Deflation Problem |
2017-04-26 | Malfunction | None | Deflation Problem |
2017-04-26 | Malfunction | None | Deflation Problem |
2017-04-26 | Malfunction | None | Deflation Problem |
2017-04-13 | Malfunction | None | Deflation Problem, Inflation Problem |
2017-04-12 | Malfunction | None | Deflation Problem |
2017-03-29 | Malfunction | None | Deflation Problem |
2017-03-23 | Malfunction | None | Inflation Problem |
2017-03-20 | Malfunction | None | Deflation Problem |
2017-03-15 | Malfunction | None | Deflation Problem |
2017-03-15 | Malfunction | None | Deflation Problem |
2017-03-01 | Malfunction | None | Inflation Problem |
2017-02-27 | Malfunction | None | Inflation Problem |
2017-02-22 | Injury | None | Inflation Problem |
2017-02-22 | Injury | None | Inflation Problem |
2017-02-15 | Malfunction | None | Deflation Problem |
2017-02-15 | Malfunction | None | Deflation Problem |
2017-02-14 | Malfunction | None | Appropriate Term/Code Not Available |
2017-02-13 | Injury | None | Inflation Problem |
2017-02-09 | Malfunction | None | Deflation Problem |
2017-02-01 | Malfunction | None | Deflation Problem |
2017-01-27 | Malfunction | None | Insufficient Information |
2017-01-25 | Malfunction | None | Material Too Rigid or Stiff, Material Integrity Problem |
2017-01-20 | Injury | None | Crack |
2017-01-20 | Injury | None | Inflation Problem |
2017-01-20 | Injury | None | Inflation Problem |
2017-01-20 | Injury | None | Inflation Problem |
2017-01-20 | Injury | None | Inflation Problem |
2017-01-19 | Malfunction | None | Deflation Problem |
2017-01-19 | Injury | None | Inflation Problem |
2017-01-19 | Injury | None | Inflation Problem |
2017-01-19 | Injury | None | Leak/Splash |
2017-01-18 | Injury | None | Inflation Problem |
2017-01-17 | Injury | None | Hole In Material, Leak/Splash |
2017-01-17 | Death | None | Inflation Problem, Leak/Splash |
2017-01-17 | Malfunction | None | Deflation Problem |
2017-01-16 | Injury | None | Air Leak |
2017-01-16 | Injury | None | Air Leak |
2017-01-16 | Injury | None | Air Leak |
2017-01-13 | Injury | None | Inflation Problem |
2017-01-13 | Injury | None | Air Leak, Deflation Problem |
2017-01-12 | Malfunction | None | Deflation Problem, Inflation Problem |
2017-01-12 | Malfunction | None | Deflation Problem |
2017-01-12 | Malfunction | None | Deflation Problem |
2017-01-12 | Malfunction | None | Deflation Problem |
2017-01-12 | Malfunction | None | Deflation Problem |
2017-01-12 | Malfunction | None | Noise, Audible |
2017-01-11 | Injury | None | Leak/Splash |
2017-01-11 | Malfunction | None | Inflation Problem |
2017-01-10 | Injury | None | Inflation Problem |
2017-01-10 | Injury | None | Device Operates Differently Than Expected |
2017-01-10 | Injury | None | Device Operates Differently Than Expected |
2017-01-10 | Injury | None | Adverse Event Without Identified Device or Use Problem |
2017-01-09 | Injury | None | Hole In Material, Leak/Splash |
2017-01-06 | Malfunction | None | Device Contamination with Chemical or Other Material |
2017-01-06 | Injury | None | Leak/Splash |
2017-01-06 | Injury | None | Air Leak |
2017-01-06 | Injury | None | Air Leak |
2017-01-06 | Injury | None | Device Operates Differently Than Expected |
2017-01-05 | Malfunction | None | Deflation Problem |
2017-01-05 | Injury | None | Leak/Splash |
2017-01-04 | Injury | None | Leak/Splash |
2017-01-04 | Injury | None | Deflation Problem, Decrease in Pressure |
2016-12-29 | Injury | None | Leak/Splash |
2016-12-28 | Injury | None | Leak/Splash |
2016-12-28 | Injury | None | Break, Device Emits Odor |
2016-12-28 | Malfunction | None | Deflation Problem |
2016-12-28 | Injury | None | Break, Device Emits Odor |
2016-12-26 | Malfunction | None | Deflation Problem |
2016-12-26 | Malfunction | None | Deflation Problem |
2016-12-26 | Malfunction | None | Deflation Problem |
2016-12-26 | Malfunction | None | Deflation Problem |
2016-12-26 | Malfunction | None | Deflation Problem |
2016-12-21 | Injury | None | Break, Device Emits Odor |
2016-12-21 | Malfunction | None | Physical Resistance |
2016-12-19 | Injury | None | Deflation Problem |
2016-12-16 | Injury | None | Positioning Problem |
2016-12-16 | Injury | None | Packaging Problem |
2016-12-15 | Injury | None | Air Leak |
2016-12-14 | Malfunction | None | Inflation Problem |
2016-12-13 | Malfunction | None | Deflation Problem |
2016-12-12 | Injury | None | Separation Failure |
2016-12-09 | Injury | None | Fluid/Blood Leak |
2016-12-08 | Malfunction | None | Failure To Adhere Or Bond |
2016-12-08 | Malfunction | None | Connection Problem |
2016-12-07 | Malfunction | None | Data Problem |
2016-12-06 | Injury | None | Air Leak |
2016-12-06 | Malfunction | None | Air Leak |
2016-12-06 | Injury | None | Torn Material |
2016-12-05 | Malfunction | None | Detachment Of Device Component |
2016-12-05 | Malfunction | None | Inflation Problem |
2016-12-05 | Injury | None | Deflation Problem |
2016-12-04 | Malfunction | None | Bent |
2016-12-04 | Malfunction | None | Bent, Failure to Advance |
2016-12-02 | Malfunction | None | Leak/Splash |
2016-11-30 | Malfunction | None | Inadequacy of Device Shape and/or Size |
2016-11-30 | Injury | None | Break |
2016-11-29 | Injury | None | Deflation Problem |
2016-11-29 | Injury | None | Disconnection |
2016-11-29 | Malfunction | None | Device Contamination with Chemical or Other Material, Packaging Problem |
2016-11-29 | Malfunction | None | Device Damaged Prior to Use, Device Packaging Compromised |
2016-11-29 | Malfunction | None | Device Damaged Prior to Use, Device Packaging Compromised |
2016-11-28 | Malfunction | None | Leak/Splash |
2016-11-28 | Malfunction | None | Device Contamination with Chemical or Other Material |
2016-11-24 | Malfunction | None | Contamination of Device Ingredient or Reagent |
2016-11-24 | Injury | None | Leak/Splash |
2016-11-23 | Injury | None | Break, Detachment Of Device Component |
2016-11-22 | Malfunction | None | Device Contamination with Chemical or Other Material, Packaging Problem |
2016-11-22 | Injury | None | Air Leak |
2016-11-22 | Malfunction | None | Device Packaging Compromised, Device Contamination with Chemical or Other Material |
2016-11-22 | Malfunction | None | Device Contamination with Chemical or Other Material, Packaging Problem |
2016-11-22 | Injury | None | Device Damaged Prior to Use, Device Contamination with Chemical or Other Material, Packaging Problem |
2016-11-22 | Malfunction | None | Device Contamination with Chemical or Other Material, Packaging Problem |
2016-11-22 | Malfunction | None | Device Contamination with Chemical or Other Material, Packaging Problem |
2016-11-22 | Malfunction | None | Device Packaging Compromised, Device Contamination with Chemical or Other Material |
2016-11-22 | Malfunction | None | Device Packaging Compromised, Device Contamination with Chemical or Other Material |
2016-11-22 | Malfunction | None | Device Packaging Compromised |
2016-11-22 | Malfunction | None | Device Contamination with Chemical or Other Material |
2016-11-22 | Malfunction | None | Device Damaged Prior to Use, Device Contamination with Chemical or Other Material |
2016-11-22 | Malfunction | None | Device Damaged Prior to Use, Device Packaging Compromised |
2016-11-22 | Injury | None | Deflation Problem |
2016-11-22 | Malfunction | None | Device Damaged Prior to Use, Device Packaging Compromised |
2016-11-22 | Malfunction | None | Device Damaged Prior to Use, Device Packaging Compromised |
2016-11-22 | Malfunction | None | Device Damaged Prior to Use, Device Packaging Compromised |
2016-11-22 | Malfunction | None | Device Damaged Prior to Use, Device Contamination with Chemical or Other Material |
2016-11-21 | Injury | None | Inflation Problem |
2016-11-20 | Malfunction | None | Bent |
2016-11-19 | Injury | None | Inflation Problem |
2016-11-19 | Injury | None | Leak/Splash |
2016-11-18 | Injury | None | Device Contamination with Chemical or Other Material |
2016-11-18 | Injury | None | Leak/Splash |
2016-11-17 | Injury | None | Leak/Splash |
2016-11-17 | Injury | None | Leak/Splash |
2016-11-16 | Malfunction | None | Leak/Splash |
2016-11-16 | Injury | None | Break |
2016-11-16 | Malfunction | None | Incomplete or Missing Packaging |
2016-11-16 | Injury | None | Break, Inflation Problem |
2016-11-15 | Injury | None | Detachment Of Device Component, Hole In Material |
2016-11-15 | Malfunction | None | Leak/Splash, Torn Material |
2016-11-10 | Injury | None | Disconnection, Stretched |
2016-11-09 | Malfunction | None | Deflation Problem |
2016-11-08 | Malfunction | None | Break |
2016-11-08 | Malfunction | None | Torn Material |
2016-11-07 | Malfunction | None | Deflation Problem |
2016-11-07 | Injury | None | Inflation Problem |
2016-11-02 | Malfunction | None | Deflation Problem |
2016-11-02 | Injury | None | Leak/Splash |
2016-11-02 | Injury | None | Decrease in Pressure, Defective Device |
2016-11-01 | Injury | None | Inflation Problem |
2016-11-01 | Injury | None | Inflation Problem |
2016-10-28 | Malfunction | None | Deflation Problem, No Pressure |
2016-10-28 | Injury | None | Inflation Problem |
2016-10-27 | Malfunction | None | Deflation Problem |
2016-10-27 | Malfunction | None | Leak/Splash |
2016-10-27 | Malfunction | None | Leak/Splash |
2016-10-27 | Injury | None | Fluid/Blood Leak |
2016-10-26 | Malfunction | None | Inflation Problem |
2016-10-26 | Injury | None | Connection Problem |
2016-10-26 | Malfunction | None | Deflation Problem |
2016-10-26 | Malfunction | None | Deflation Problem |
2016-10-25 | Malfunction | None | Inadequacy of Device Shape and/or Size |
2016-10-25 | Malfunction | None | Incorrect Or Inadequate Test Results |
2016-10-25 | Malfunction | None | Deflation Problem |
2016-10-24 | Injury | None | Material Rupture |
2016-10-20 | Injury | None | Inflation Problem |
2016-10-20 | Malfunction | None | Material Integrity Problem |
2016-10-19 | Injury | None | Packaging Problem |
2016-10-18 | Malfunction | None | Inflation Problem |
2016-10-18 | Malfunction | None | Burst Container or Vessel |
2016-10-18 | Malfunction | None | Deflation Problem |
2016-10-18 | Injury | None | Pressure Problem |
2016-10-17 | Injury | None | Inflation Problem |
2016-10-14 | Malfunction | None | Inflation Problem |
2016-10-12 | Malfunction | None | Air Leak |
2016-10-11 | Injury | None | Device Operates Differently Than Expected |
2016-10-06 | Malfunction | None | Connection Problem |
2016-10-06 | Malfunction | None | Inflation Problem |
2016-10-06 | Injury | None | Leak/Splash |
2016-10-06 | Malfunction | None | Device Operates Differently Than Expected |
2016-10-06 | Injury | None | Device Markings/Labelling Problem |
2016-10-06 | Injury | None | Device Operates Differently Than Expected |
2016-10-06 | Injury | None | Leak/Splash |
2016-10-06 | Injury | None | Device Dislodged or Dislocated, Material Integrity Problem |
2016-10-06 | Injury | None | Device Operates Differently Than Expected |
2016-10-06 | Injury | None | Leak/Splash |
2016-10-06 | Injury | None | Device Markings/Labelling Problem |
2016-10-06 | Injury | None | Leak/Splash |
2016-10-06 | Injury | None | Device Markings/Labelling Problem |
2016-10-06 | Injury | None | Device Markings/Labelling Problem |
2016-10-06 | Injury | None | Leak/Splash |
2016-10-06 | Injury | None | Hole In Material, Leak/Splash |
2016-10-06 | Injury | None | Fluid/Blood Leak |
2016-10-05 | Malfunction | None | Inflation Problem |
2016-10-05 | Injury | None | Material Integrity Problem |
2016-10-04 | Injury | None | Improper or Incorrect Procedure or Method, Material Deformation |
2016-10-03 | Malfunction | None | Inflation Problem |
2016-10-03 | Malfunction | None | Deflation Problem |
2016-10-03 | Malfunction | None | Inflation Problem |
2016-10-03 | Malfunction | None | Deflation Problem |
2016-10-03 | Injury | None | Device Operates Differently Than Expected |
2016-10-03 | Malfunction | None | Deflation Problem |
2016-09-30 | Injury | None | Air Leak, Increase in Pressure |
2016-09-30 | Injury | None | Deflation Problem, Hole In Material, Material Rupture |
2016-09-30 | Injury | None | Deflation Problem, Hole In Material, Material Rupture |
2016-09-30 | Injury | None | Deflation Problem, Hole In Material, Material Rupture |
2016-09-30 | Injury | None | Deflation Problem, Hole In Material, Material Rupture |
2016-09-30 | Injury | None | Deflation Problem, Hole In Material, Material Rupture |
2016-09-30 | Injury | None | Leak/Splash |
2016-09-29 | Malfunction | None | Inflation Problem |
2016-09-29 | Injury | None | Hole In Material, Material Rupture |
2016-09-29 | Injury | None | Hole In Material |
2016-09-29 | Death | None | Leak/Splash |
2016-09-29 | Malfunction | None | Kinked |
2016-09-29 | Malfunction | None | Bent, Device Damaged Prior to Use |
2016-09-29 | Malfunction | None | Inflation Problem |
2016-09-28 | Injury | None | Device Slipped, Connection Problem, Device Operates Differently Than Expected |
2016-09-28 | Injury | None | Device Operates Differently Than Expected |
2016-09-28 | Injury | None | Inflation Problem |
2016-09-26 | Injury | None | Inadequacy of Device Shape and/or Size |
2016-09-26 | Malfunction | None | Inflation Problem |
2016-09-26 | Injury | None | Inflation Problem, Leak/Splash |
2016-09-25 | Injury | None | Air Leak, Hole In Material |
2016-09-25 | Injury | None | Hole In Material, Leak/Splash |
2016-09-23 | Injury | None | Kinked |
2016-09-23 | Injury | None | Deflation Problem, Inflation Problem |
2016-09-23 | Injury | None | Leak/Splash |
2016-09-20 | Injury | None | Scratched Material |
2016-09-20 | Injury | None | Scratched Material |
2016-09-20 | Injury | None | Scratched Material |
2016-09-19 | Injury | None | Entrapment of Device, Malposition of Device, Material Deformation |
2016-09-19 | Malfunction | None | Torn Material |
2016-09-16 | Malfunction | None | Bent |
2016-09-16 | Injury | None | Detachment Of Device Component |
2016-09-16 | Malfunction | None | Inflation Problem |
2016-09-16 | Injury | None | Deflation Problem |
2016-09-15 | Malfunction | None | Inflation Problem |
2016-09-14 | Malfunction | None | Inflation Problem |
2016-09-14 | Malfunction | None | Detachment Of Device Component |
2016-09-14 | Malfunction | None | Deflation Problem |
2016-09-14 | Injury | None | Leak/Splash |
2016-09-13 | Injury | None | Increase in Pressure |
2016-09-13 | Malfunction | None | Deflation Problem |
2016-09-13 | Malfunction | None | Inflation Problem |
2016-09-12 | Injury | None | Inflation Problem |
2016-09-12 | Injury | None | Device Displays Incorrect Message |
2016-09-08 | Malfunction | None | Deflation Problem |
2016-09-08 | Injury | None | Migration or Expulsion of Device |
2016-09-07 | Injury | None | Device Operates Differently Than Expected |
2016-09-07 | Injury | None | Break |
2016-09-07 | Malfunction | None | Detachment of Device or Device Component |
2016-09-06 | Injury | None | Failure to Align |
2016-09-06 | Injury | None | Leak/Splash |
2016-09-06 | Malfunction | None | Deflation Problem |
2016-09-05 | Malfunction | None | Device Markings/Labelling Problem |
2016-09-05 | Malfunction | None | Deflation Problem |
2016-09-05 | Malfunction | None | Inflation Problem |
2016-09-05 | Malfunction | None | Deflation Problem |
2016-09-04 | Malfunction | None | Leak/Splash |
2016-09-02 | Injury | None | Inflation Problem |
2016-09-02 | Malfunction | None | Deflation Problem |
2016-09-02 | Malfunction | None | Deflation Problem |
2016-09-02 | Injury | None | Device Operates Differently Than Expected |
2016-09-01 | Malfunction | None | Material Deformation |
2016-08-31 | Injury | None | Inflation Problem |
2016-08-31 | Malfunction | None | Break |
2016-08-29 | Injury | None | Inflation Problem, Leak/Splash |
2016-08-29 | Malfunction | None | Deflation Problem |
2016-08-29 | Injury | None | Inflation Problem, Leak/Splash, Device Operates Differently Than Expected |
2016-08-29 | Malfunction | None | Deflation Problem |
2016-08-24 | Malfunction | None | Deflation Problem |
2016-08-24 | Injury | None | Air Leak |
2016-08-23 | Injury | None | Leak/Splash |
2016-08-23 | Malfunction | None | Inflation Problem |
2016-08-23 | Malfunction | None | Connection Problem |
2016-08-23 | Malfunction | None | Inflation Problem |
2016-08-23 | Malfunction | None | Misconnection |
2016-08-22 | Injury | None | Inflation Problem |
2016-08-19 | Injury | None | Device Markings/Labelling Problem |
2016-08-18 | Injury | None | Device Operates Differently Than Expected |
2016-08-17 | Injury | None | Detachment of Device or Device Component |
2016-08-16 | Malfunction | None | Deflation Problem |
2016-08-15 | Malfunction | None | Device Operates Differently Than Expected |
2016-08-15 | Injury | None | Device Markings/Labelling Problem |
2016-08-11 | Injury | None | Deflation Problem, Leak/Splash |
2016-08-11 | Injury | None | Inflation Problem |
2016-08-11 | Malfunction | None | Air Leak |
2016-08-11 | Injury | None | Inflation Problem, Leak/Splash |
2016-08-10 | Injury | None | Occlusion Within Device, Device Displays Incorrect Message |
2016-08-10 | Malfunction | None | Deflation Problem |
2016-08-09 | Malfunction | None | Inflation Problem |
2016-08-09 | Injury | None | Inflation Problem |
2016-08-08 | Malfunction | None | Break |
2016-08-08 | Injury | None | Device Operates Differently Than Expected |
2016-08-08 | Injury | None | Deflation Problem |
2016-08-08 | Injury | None | Deflation Problem |
2016-08-08 | Malfunction | None | Inflation Problem |
2016-08-07 | Injury | None | Inflation Problem |
2016-08-03 | Injury | None | Break, Detachment Of Device Component |
2016-08-03 | Malfunction | None | Leak/Splash |
2016-08-02 | Injury | None | Deflation Problem |
2016-08-02 | Injury | None | Inflation Problem |
2016-08-02 | Injury | None | Inflation Problem |
2016-07-29 | Injury | None | Pressure Problem |
2016-07-29 | Injury | None | No Pressure |
2016-07-29 | Injury | None | No Pressure |
2016-07-27 | Injury | None | Inflation Problem |
2016-07-27 | Injury | None | Leak/Splash |
2016-07-27 | Injury | None | Break, Detachment Of Device Component |
2016-07-26 | Injury | None | Component Missing |
2016-07-22 | Malfunction | None | Deflation Problem |
2016-07-21 | Malfunction | None | Inflation Problem |
2016-07-20 | Malfunction | None | Inflation Problem |
2016-07-20 | Malfunction | None | Inflation Problem |
2016-07-20 | Malfunction | None | Inflation Problem |
2016-07-20 | Malfunction | None | Inflation Problem |
2016-07-20 | Malfunction | None | Inflation Problem |
2016-07-20 | Malfunction | None | Inflation Problem |
2016-07-20 | Malfunction | None | Inflation Problem |
2016-07-20 | Malfunction | None | Inflation Problem |
2016-07-20 | Malfunction | None | Inflation Problem |
2016-07-20 | Malfunction | None | Inflation Problem |
2016-07-20 | Malfunction | None | Inflation Problem |
2016-07-20 | Malfunction | None | Inflation Problem |
2016-07-20 | Malfunction | None | Inflation Problem |
2016-07-20 | Malfunction | None | Inflation Problem |
2016-07-20 | Malfunction | None | Inflation Problem |
2016-07-20 | Malfunction | None | Inflation Problem |
2016-07-20 | Malfunction | None | Inflation Problem |
2016-07-20 | Malfunction | None | Inflation Problem |
2016-07-20 | Malfunction | None | Inflation Problem |
2016-07-20 | Malfunction | None | Inflation Problem |
2016-07-19 | Injury | None | Pressure Problem |
2016-07-15 | Malfunction | None | Deflation Problem |
2016-07-15 | Malfunction | None | Inflation Problem |
2016-07-15 | Malfunction | None | Deflation Problem |
2016-07-15 | Injury | None | Inflation Problem |
2016-07-15 | Malfunction | None | Deflation Problem |
2016-07-15 | Malfunction | None | Deflation Problem |
2016-07-13 | Malfunction | None | Insufficient Information |
2016-07-13 | Malfunction | None | Bent, Material Integrity Problem |
2016-07-13 | Malfunction | None | Deflation Problem |
2016-07-13 | Malfunction | None | Inflation Problem |
2016-07-12 | Malfunction | None | Inflation Problem |
2016-07-11 | Malfunction | None | Inflation Problem |
2016-07-11 | Malfunction | None | Inflation Problem |
2016-07-11 | Malfunction | None | Inflation Problem |
2016-07-11 | Malfunction | None | Inflation Problem |
2016-07-11 | Malfunction | None | Inflation Problem |
2016-07-11 | Malfunction | None | Inflation Problem |
2016-07-11 | Malfunction | None | Inflation Problem |
2016-07-11 | Malfunction | None | Inflation Problem |
2016-07-11 | Malfunction | None | Inflation Problem |
2016-07-11 | Malfunction | None | Air Leak |
2016-07-11 | Malfunction | None | Deflation Problem |
2016-07-11 | Malfunction | None | Deflation Problem |
2016-07-11 | Injury | None | Detachment Of Device Component, Disconnection, Difficult to Insert |
2016-07-11 | Malfunction | None | Inflation Problem |
2016-07-08 | Malfunction | None | Occlusion Within Device |
2016-07-05 | Malfunction | None | Deflation Problem |
2016-06-30 | Injury | None | Leak/Splash |
2016-06-08 | Malfunction | None | Inflation Problem |
2016-05-17 | Injury | None | Break, Leak/Splash |
2016-05-12 | Injury | None | Disconnection |
2016-05-03 | Injury | None | Obstruction of Flow |
2016-04-16 | Injury | None | Hole In Material, Inflation Problem |
2016-04-08 | Injury | None | Leak/Splash |
2016-03-06 | Injury | None | Leak/Splash |
2016-02-11 | Injury | None | Leak/Splash |
2016-02-08 | Injury | Low Blood Pressure/ Hypotension, Pneumothorax, Tissue Breakdown, Unintended Radiation Exposure | Appropriate Term/Code Not Available |
2016-01-04 | Injury | None | Leak/Splash |
2015-12-30 | Injury | None | Leak/Splash |
2015-12-28 | Injury | None | Leak/Splash |
2015-05-28 | Unknown | None | Material Deformation |
2015-05-16 | Injury | None | Break |
2015-05-12 | Injury | None | Device Operates Differently Than Expected |
2015-05-11 | Injury | None | Entrapment of Device, Suction Problem, Improper Device Output |
2015-05-11 | Injury | None | Break |
2015-05-11 | Injury | None | Peeled/Delaminated |
2015-05-11 | Injury | None | Inflation Problem |
2015-05-08 | Injury | None | Inflation Problem |
2015-05-08 | Injury | None | Device Operates Differently Than Expected |
2015-05-08 | Injury | None | Inflation Problem |
2015-05-07 | Malfunction | None | Device Operates Differently Than Expected |
2015-05-01 | Malfunction | None | Deflation Problem |
2015-05-01 | Malfunction | None | Deflation Problem |
2015-05-01 | Malfunction | None | Deflation Problem |
2015-04-30 | Malfunction | None | Kinked |
2015-04-29 | Malfunction | None | Leak/Splash |
2015-04-29 | Injury | None | Leak/Splash |
2015-04-27 | Injury | None | Break |
2015-04-27 | Injury | None | Bent, Ventilation Problem in Device Environment |
2015-04-24 | Malfunction | None | Inflation Problem, Device Displays Incorrect Message |
2015-04-24 | Injury | None | Inflation Problem |
2015-04-23 | Malfunction | None | Deflation Problem |
2015-04-23 | Malfunction | None | Deflation Problem |
2015-04-23 | Malfunction | None | Component Missing, Device Or Device Fragments Location Unknown |
2015-04-21 | Injury | None | Torn Material |
2015-04-21 | Malfunction | None | Fluid/Blood Leak |
2015-04-20 | Malfunction | None | Hole In Material |
2015-04-17 | Malfunction | None | Deflation Problem |
2015-04-17 | Malfunction | None | Deflation Problem |
2015-04-17 | Injury | None | No Pressure |
2015-04-17 | Injury | None | Torn Material |
2015-04-16 | Malfunction | None | Deflation Problem |
2015-04-16 | Malfunction | None | Air Leak |
2015-04-15 | Injury | None | Inflation Problem |
2015-04-15 | Malfunction | None | Inadequacy of Device Shape and/or Size |
2015-04-14 | Malfunction | None | Mechanics Altered |
2015-04-14 | Malfunction | None | Connection Problem |
2015-04-14 | Malfunction | None | Loose or Intermittent Connection |
2015-04-14 | Malfunction | None | Device Operates Differently Than Expected |
2015-04-14 | Malfunction | None | Difficult to Open or Close |
2015-04-14 | Injury | None | Connection Problem, Device Operates Differently Than Expected |
2015-04-13 | Malfunction | None | Mechanics Altered |
2015-04-13 | Injury | None | Deflation Problem |
2015-04-13 | Malfunction | None | Loose or Intermittent Connection |
2015-04-13 | Malfunction | None | Deflation Problem |
2015-04-12 | Injury | None | Disconnection |
2015-04-10 | Injury | None | Break |
2015-04-09 | Malfunction | None | Burst Container or Vessel |
2015-04-08 | Malfunction | None | Deflation Problem |
2015-04-08 | Malfunction | None | Deflation Problem |
2015-04-08 | Injury | None | Deflation Problem |
2015-04-07 | Injury | None | Failure to Disconnect |
2015-04-07 | Injury | None | Inflation Problem |
2015-04-07 | Injury | None | Device Operates Differently Than Expected |
2015-04-07 | Injury | None | Deflation Problem |
2015-04-07 | Injury | None | Difficult to Remove, Connection Problem |
2015-04-07 | Injury | None | Difficult to Remove, Inadequacy of Device Shape and/or Size |
2015-04-07 | Malfunction | None | Inflation Problem |
2015-04-03 | Malfunction | None | Deflation Problem |
2015-04-03 | Malfunction | None | Air Leak, Inflation Problem |
2015-04-02 | Injury | None | Inadequacy of Device Shape and/or Size |
2015-04-01 | Malfunction | None | Air Leak, Inflation Problem |
2015-04-01 | Malfunction | None | Deflation Problem |
2015-04-01 | Malfunction | None | Air Leak, Inflation Problem |
2015-04-01 | Malfunction | None | Deflation Problem |
2015-04-01 | Malfunction | None | Deflation Problem |
2015-04-01 | Malfunction | None | Deflation Problem |
2015-04-01 | Malfunction | None | Leak/Splash |
2015-04-01 | Malfunction | None | Deflation Problem |
2015-04-01 | Malfunction | None | Deflation Problem |
2015-04-01 | Malfunction | None | Deflation Problem |
2015-04-01 | Malfunction | None | Deflation Problem |
2015-04-01 | Malfunction | None | Deflation Problem |
2015-04-01 | Malfunction | None | Deflation Problem |
2015-04-01 | Injury | None | Increase in Pressure |
2015-03-31 | Injury | None | Insufficient Information |
2015-03-31 | Malfunction | None | Deflation Problem |
2015-03-26 | Malfunction | None | Structural Problem |
2015-03-26 | Malfunction | None | Bent, Folded |
2015-03-26 | Injury | None | Sticking |
2015-03-25 | Malfunction | None | Sticking, Mechanical Jam |
2015-03-24 | Injury | None | Inflation Problem |
2015-03-24 | Injury | None | Leak/Splash |
2015-03-20 | Malfunction | None | Inflation Problem, Physical Resistance |
2015-03-19 | Malfunction | None | Deflation Problem, Device Operates Differently Than Expected |
2015-03-18 | Malfunction | None | Deflation Problem |
2015-03-18 | Injury | None | Leak/Splash |
2015-03-17 | Injury | None | Material Puncture/Hole |
2015-03-17 | Injury | None | Material Puncture/Hole |
2015-03-14 | Malfunction | None | Deflation Problem, Hole In Material |
2015-03-13 | Malfunction | None | Fitting Problem |
2015-03-09 | Injury | None | Deflation Problem |
2015-03-03 | Injury | None | Break |
2015-03-03 | Injury | None | Unintended Movement |
2015-01-22 | Injury | None | Deflation Problem |
2014-09-24 | Injury | None | Torn Material |
2014-07-22 | Injury | None | Leak/Splash |
2014-07-18 | Malfunction | None | Material Puncture/Hole |
2014-07-11 | Malfunction | None | Inflation Problem |
2014-07-08 | Malfunction | None | Deflation Problem |
2014-07-07 | Injury | None | Device Operates Differently Than Expected |
2014-07-01 | Injury | None | Leak/Splash, Noise, Audible |
2014-07-01 | Injury | None | Leak/Splash |
2014-06-27 | Malfunction | None | Air Leak |
2014-06-26 | Injury | None | Break, Incorrect Or Inadequate Test Results |
2014-06-23 | Injury | None | Component Falling |
2014-06-22 | Injury | None | Burst Container or Vessel, Leak/Splash |
2014-06-22 | Injury | None | Material Separation |
2014-06-20 | Malfunction | None | Sticking |
2014-06-20 | Injury | None | Leak/Splash |
2014-06-19 | Malfunction | None | Compatibility Problem, Packaging Problem |
2014-06-19 | Malfunction | None | Leak/Splash |
2014-06-18 | Injury | None | Material Deformation |
2014-06-17 | Injury | None | Deflation Problem |
2014-06-16 | Malfunction | None | Air Leak |
2014-06-16 | Injury | None | Air Leak |
2014-06-12 | Injury | None | Device Displays Incorrect Message, Device Operates Differently Than Expected |
2014-06-11 | Malfunction | None | Material Too Rigid or Stiff, Fitting Problem |
2014-06-10 | Injury | None | Deflation Problem |
2014-06-09 | Injury | None | Crack |
2014-06-09 | Other | None | Device Contamination with Chemical or Other Material |
2014-06-09 | Injury | None | Inflation Problem |
2014-06-09 | Malfunction | None | Inflation Problem |
2014-06-09 | Malfunction | None | Material Too Rigid or Stiff |
2014-06-06 | Death | None | Detachment Of Device Component |
2014-06-05 | Malfunction | None | Incorrect Device Or Component Shipped |
2014-06-02 | Injury | None | Air Leak, Crack |
2014-05-31 | Injury | None | Deflation Problem |
2014-05-28 | Malfunction | None | Leak/Splash |
2014-05-27 | Malfunction | None | Deflation Problem |
2014-05-27 | Malfunction | None | Deflation Problem |
2014-05-27 | Malfunction | None | Inflation Problem |
2014-05-27 | Malfunction | None | Air Leak |
2014-05-27 | Malfunction | None | Deflation Problem |
2014-05-23 | Malfunction | None | Leak/Splash |
2014-05-23 | Malfunction | None | Leak/Splash |
2014-05-21 | Injury | None | Air Leak, Crack |
2014-05-20 | Injury | None | Air Leak |
2014-05-15 | Injury | None | Detachment Of Device Component |
2014-05-14 | Injury | None | Air Leak, Inflation Problem |
2014-05-11 | Injury | None | Break, Detachment of Device or Device Component |
2014-05-01 | Injury | None | Material Protrusion/Extrusion |
2014-05-01 | Injury | None | Deflation Problem, Leak/Splash |
2014-05-01 | Injury | None | No Pressure |
2014-05-01 | Malfunction | None | Break |
2014-04-22 | Injury | None | Air Leak, Crack |
2014-04-11 | Injury | None | Detachment Of Device Component |
2014-04-03 | Injury | None | Air Leak, Device Displays Incorrect Message |
2014-04-01 | Malfunction | None | Mechanical Problem |
2014-04-01 | Malfunction | None | Device Operates Differently Than Expected |
2014-04-01 | Injury | None | Scratched Material |
2014-04-01 | Injury | None | Device Operates Differently Than Expected, Material Integrity Problem |
2014-04-01 | Malfunction | None | Detachment Of Device Component |
2014-04-01 | Injury | None | Scratched Material |
2014-03-31 | Injury | None | Material Separation |
2014-03-28 | Injury | None | Device Operates Differently Than Expected |
2014-03-24 | Malfunction | None | Material Deformation, Material Twisted/Bent |
2014-03-08 | Malfunction | None | Crack |
2014-03-04 | Injury | None | Air Leak |
2014-03-04 | Injury | None | Leak/Splash |
2014-03-04 | Injury | None | Leak/Splash |
2014-03-01 | Injury | None | Device Operates Differently Than Expected |
2014-03-01 | Injury | None | Crack |
2014-03-01 | Injury | None | Device Operates Differently Than Expected |
2014-03-01 | Injury | None | Leak/Splash |
2014-03-01 | Injury | None | Decrease in Suction |
2014-03-01 | Malfunction | None | Device Operates Differently Than Expected, Pressure Problem |
2014-02-21 | Malfunction | None | Leak/Splash |
2014-02-17 | Malfunction | None | Inflation Problem |
2014-02-12 | Injury | None | Crack |
2014-02-11 | Injury | None | Difficult to Insert, Structural Problem |
2014-02-11 | Injury | None | Difficult to Insert, Material Integrity Problem |
2014-02-07 | Malfunction | None | Loose or Intermittent Connection, Nonstandard Device |
2014-02-03 | Malfunction | None | Connection Problem |
2014-02-01 | Malfunction | None | Device Operates Differently Than Expected |
2014-02-01 | Malfunction | None | Sticking |
2014-02-01 | Malfunction | None | Mechanics Altered |
2014-02-01 | Injury | None | Leak/Splash |
2014-02-01 | Injury | None | Leak/Splash |
2014-02-01 | Injury | None | Material Twisted/Bent |
2014-02-01 | Injury | None | Leak/Splash |
2014-02-01 | Injury | None | Leak/Splash |
2014-02-01 | Malfunction | None | Loose or Intermittent Connection, Material Separation |
2014-01-28 | Malfunction | None | Split |
2014-01-28 | Malfunction | None | Inflation Problem |
2014-01-24 | Malfunction | None | Material Discolored |
2014-01-22 | Malfunction | None | Defective Device |
2014-01-20 | Unknown | None | Device Slipped, Fitting Problem |
2014-01-20 | Malfunction | None | Fitting Problem |
2014-01-20 | Malfunction | None | Device Operates Differently Than Expected, Positioning Problem |
2014-01-18 | Injury | None | Inflation Problem, Material Puncture/Hole |
2014-01-15 | Injury | None | Device Contamination with Chemical or Other Material |
2014-01-13 | Injury | None | Air Leak, Device Operates Differently Than Expected |
2014-01-01 | Injury | None | Device Operates Differently Than Expected, Material Integrity Problem |
2014-01-01 | Malfunction | None | Air Leak |
2014-01-01 | Death | None | Pressure Problem |
2014-01-01 | Injury | None | Leak/Splash |
2014-01-01 | Injury | None | Appropriate Term/Code Not Available |
2014-01-01 | Injury | None | Leak/Splash |
2014-01-01 | Injury | None | Device Operates Differently Than Expected, Material Integrity Problem |
2014-01-01 | Injury | None | Device Operates Differently Than Expected |
2014-01-01 | Injury | None | Leak/Splash |
2014-01-01 | Injury | None | Leak/Splash |
2014-01-01 | Injury | None | Leak/Splash |
2014-01-01 | Injury | None | Leak/Splash |
2014-01-01 | Injury | None | Structural Problem |
2014-01-01 | Injury | None | Device Operates Differently Than Expected, Material Integrity Problem |
2014-01-01 | Injury | None | Detachment Of Device Component, Material Integrity Problem |
2014-01-01 | Injury | None | Structural Problem |
2014-01-01 | Injury | None | Leak/Splash |
2014-01-01 | Injury | None | Leak/Splash |
2014-01-01 | Injury | None | Loose or Intermittent Connection |
2014-01-01 | Injury | None | Leak/Splash |
2014-01-01 | Injury | None | Structural Problem |
2014-01-01 | Injury | None | Restricted Flow rate, Improper Flow or Infusion |
2014-01-01 | Injury | None | Hole In Material, Leak/Splash |
2014-01-01 | Injury | None | Inadequacy of Device Shape and/or Size, Patient-Device Incompatibility |
2014-01-01 | Injury | None | Leak/Splash |
2014-01-01 | Injury | None | Break, Device Slipped |
2014-01-01 | Malfunction | None | Defective Component, Malposition of Device |
2014-01-01 | Malfunction | None | Defective Component, Malposition of Device |
2014-01-01 | Malfunction | None | Break |
2014-01-01 | Malfunction | None | Break |
2014-01-01 | Malfunction | None | Compatibility Problem, Packaging Problem |
2014-01-01 | Malfunction | None | Defective Component |
2014-01-01 | Malfunction | None | Inadequacy of Device Shape and/or Size, Patient-Device Incompatibility |
2014-01-01 | Malfunction | None | Leak/Splash |
2014-01-01 | Injury | None | Break, Detachment Of Device Component |
2014-01-01 | Injury | None | Kinked |
2014-01-01 | Malfunction | None | Obstruction of Flow |
2014-01-01 | Malfunction | None | Connection Problem |
2014-01-01 | Malfunction | None | Packaging Problem |
2014-01-01 | Malfunction | None | Device Slipped |
2014-01-01 | Malfunction | None | Mechanics Altered |
2014-01-01 | Injury | None | Torn Material |
2014-01-01 | Malfunction | None | Fitting Problem |
2014-01-01 | Malfunction | None | Occlusion Within Device |
2014-01-01 | Malfunction | None | Connection Problem |
2014-01-01 | Malfunction | None | Connection Problem |
2013-12-26 | Malfunction | None | Air Leak |
2013-12-25 | Malfunction | None | Air Leak |
2013-12-24 | Malfunction | None | Crack |
2013-12-23 | Injury | None | Break |
2013-12-18 | Malfunction | None | Air Leak |
2013-12-16 | Injury | None | Positioning Problem |
2013-12-13 | Injury | None | Torn Material |
2013-12-03 | Malfunction | None | Crack |
2013-12-01 | Injury | None | Difficult to Insert |
2013-12-01 | Injury | None | Deflation Problem |
2013-12-01 | Injury | None | Deflation Problem |
2013-12-01 | Injury | None | Leak/Splash |
2013-12-01 | Malfunction | None | Crack |
2013-12-01 | Malfunction | None | Leak/Splash |
2013-11-28 | Injury | None | Migration or Expulsion of Device |
2013-11-25 | Injury | None | None |
2013-11-20 | Injury | None | None |
2013-11-19 | Injury | None | Leak/Splash |
2013-11-18 | Malfunction | None | None |
2013-11-18 | Injury | None | None |
2013-11-18 | Malfunction | None | None |
2013-11-11 | Death | None | None |
2013-11-08 | Injury | None | None |
2013-11-07 | Malfunction | None | None |
2013-11-01 | Malfunction | None | None |
2013-10-31 | Injury | None | Inadequacy of Device Shape and/or Size |
2013-10-30 | Malfunction | None | None |
2013-10-29 | Malfunction | None | None |
2013-10-28 | Injury | None | Misconnection |
2013-10-25 | Malfunction | None | None |
2013-10-24 | Injury | None | Air Leak |
2013-10-24 | Injury | None | None |
2013-10-18 | Malfunction | None | None |
2013-10-16 | Malfunction | None | None |
2013-10-13 | Injury | None | None |
2013-10-10 | Injury | None | None |
2013-10-07 | Injury | None | None |
2013-10-04 | Malfunction | None | None |
2013-10-04 | Malfunction | None | None |
2013-10-03 | Injury | None | Fitting Problem |
2013-10-03 | Injury | None | None |
2013-10-02 | Other | None | None |
2013-10-02 | Malfunction | None | None |
2013-10-01 | Injury | None | None |
2013-10-01 | Injury | None | None |
2013-10-01 | Injury | None | None |
2013-10-01 | Injury | None | None |
2013-10-01 | Injury | None | None |
2013-10-01 | Injury | None | None |
2013-10-01 | Injury | None | None |
2013-10-01 | Malfunction | None | None |
2013-10-01 | Injury | None | None |
2013-10-01 | Malfunction | None | None |
2013-09-30 | Injury | None | None |
2013-09-30 | Injury | None | None |
2013-09-30 | Injury | None | None |
2013-09-30 | Injury | None | None |
2013-09-30 | Injury | None | None |
2013-09-24 | Injury | None | None |
2013-09-22 | Injury | None | None |
2013-09-20 | Malfunction | None | None |
2013-09-20 | Malfunction | None | None |
2013-09-20 | Malfunction | None | None |
2013-09-19 | Injury | None | None |
2013-09-19 | Injury | None | None |
2013-09-19 | Injury | None | None |
2013-09-19 | Injury | None | None |
2013-09-18 | Injury | None | None |
2013-09-17 | Malfunction | None | None |
2013-09-13 | Injury | None | None |
2013-09-13 | Injury | None | None |
2013-09-10 | Injury | None | None |
2013-09-10 | Injury | None | None |
2013-09-10 | Injury | None | None |
2013-09-10 | Injury | None | None |
2013-09-09 | Malfunction | None | Break |
2013-09-06 | Malfunction | None | Crack |
2013-09-05 | Injury | None | None |
2013-09-03 | Injury | None | None |
2013-09-03 | Injury | None | None |
2013-09-01 | Injury | None | None |
2013-09-01 | Injury | None | None |
2013-09-01 | Injury | None | None |
2013-09-01 | Injury | None | None |
2013-09-01 | Injury | None | None |
2013-09-01 | Injury | None | None |
2013-09-01 | Injury | None | None |
2013-09-01 | Injury | None | None |
2013-09-01 | Injury | None | None |
2013-09-01 | Malfunction | None | None |
2013-09-01 | Injury | None | None |
2013-09-01 | Injury | None | None |
2013-09-01 | Injury | None | None |
2013-09-01 | Injury | None | None |
2013-09-01 | Malfunction | None | None |
2013-09-01 | Injury | None | None |
2013-08-26 | Malfunction | None | None |
2013-08-23 | Injury | None | None |
2013-08-19 | Malfunction | None | None |
2013-08-15 | Injury | None | None |
2013-08-15 | Injury | None | None |
2013-08-12 | Malfunction | None | None |
2013-08-12 | Malfunction | None | None |
2013-08-12 | Malfunction | None | None |
2013-08-08 | Injury | None | None |
2013-08-08 | Injury | None | None |
2013-08-01 | Malfunction | None | None |
2013-08-01 | Injury | None | None |
2013-08-01 | Injury | None | None |
2013-08-01 | Injury | None | None |
2013-08-01 | Injury | None | None |
2013-08-01 | Injury | None | None |
2013-08-01 | Injury | None | None |
2013-08-01 | Injury | None | None |
2013-07-30 | Malfunction | None | None |
2013-07-29 | Injury | None | None |
2013-07-29 | Injury | None | None |
2013-07-29 | Injury | None | None |
2013-07-25 | Malfunction | None | None |
2013-07-24 | Injury | None | None |
2013-07-18 | Injury | None | None |
2013-07-18 | Injury | None | None |
2013-07-16 | Injury | None | None |
2013-07-15 | Malfunction | None | None |
2013-07-13 | Injury | None | None |
2013-07-10 | Malfunction | None | None |
2013-07-10 | Injury | None | None |
2013-07-10 | Malfunction | None | None |
2013-07-04 | Malfunction | None | None |
2013-07-04 | Malfunction | None | None |
2013-07-01 | Injury | None | None |
2013-07-01 | Injury | None | None |
2013-07-01 | Malfunction | None | None |
2013-07-01 | Malfunction | None | None |
2013-07-01 | Malfunction | None | None |
2013-07-01 | Malfunction | None | None |
2013-07-01 | Malfunction | None | None |
2013-06-20 | Injury | None | None |
2013-06-20 | Malfunction | None | None |
2013-06-11 | Injury | None | None |
2013-06-11 | Malfunction | None | None |
2013-06-01 | Injury | None | None |
2013-06-01 | Injury | None | None |
2013-06-01 | Injury | None | None |
2013-06-01 | Injury | None | None |
2013-06-01 | Injury | None | None |
2013-06-01 | Malfunction | None | None |
2013-06-01 | Malfunction | None | None |
2013-06-01 | Injury | None | None |
2013-06-01 | Injury | None | None |
2013-06-01 | Malfunction | None | None |
2013-05-23 | Malfunction | None | None |
2013-05-22 | Malfunction | None | None |
2013-05-20 | Injury | None | None |
2013-05-17 | Malfunction | None | None |
2013-05-15 | Malfunction | None | None |
2013-05-10 | Injury | None | None |
2013-05-10 | Malfunction | None | None |
2013-05-06 | Injury | None | None |
2013-05-01 | Malfunction | None | None |
2013-05-01 | Injury | None | None |
2013-05-01 | Injury | None | None |
2013-05-01 | Injury | None | Pressure Problem |
2013-05-01 | Malfunction | None | None |
2013-05-01 | Injury | None | None |
2013-05-01 | Injury | None | None |
2013-05-01 | Malfunction | None | None |
2013-04-29 | Injury | None | None |
2013-04-29 | Injury | None | None |
2013-04-29 | Injury | None | None |
2013-04-27 | Injury | None | None |
2013-04-26 | Injury | None | None |
2013-04-24 | Malfunction | None | None |
2013-04-23 | Injury | None | None |
2013-04-19 | Injury | None | None |
2013-04-18 | Injury | None | None |
2013-04-17 | Injury | None | Air Leak |
2013-04-16 | Injury | None | None |
2013-04-11 | Injury | None | None |
2013-04-11 | Injury | None | None |
2013-04-11 | Injury | None | None |
2013-04-10 | Malfunction | None | None |
2013-04-09 | Malfunction | None | None |
2013-04-04 | Injury | None | None |
2013-04-03 | Injury | None | None |
2013-04-02 | Injury | None | None |
2013-04-02 | Injury | None | None |
2013-04-01 | Injury | None | None |
2013-04-01 | Injury | None | None |
2013-04-01 | Injury | None | None |
2013-04-01 | Injury | None | None |
2013-04-01 | Injury | None | None |
2013-04-01 | Malfunction | None | None |
2013-04-01 | Injury | None | None |
2013-04-01 | Malfunction | None | None |
2013-04-01 | Malfunction | None | None |
2013-03-29 | Malfunction | None | None |
2013-03-29 | Malfunction | None | None |
2013-03-29 | Malfunction | None | None |
2013-03-28 | Injury | None | None |
2013-03-27 | Malfunction | None | None |
2013-03-27 | Malfunction | None | None |
2013-03-26 | Malfunction | None | None |
2013-03-26 | Malfunction | None | None |
2013-03-26 | Malfunction | None | None |
2013-03-26 | Malfunction | None | None |
2013-03-26 | Malfunction | None | None |
2013-03-25 | Malfunction | None | None |
2013-03-19 | Malfunction | None | None |
2013-03-15 | Injury | None | None |
2013-03-15 | Injury | None | None |
2013-03-01 | Injury | None | None |
2013-03-01 | Malfunction | None | None |
2013-02-17 | Malfunction | None | Leak/Splash |
2013-02-01 | Injury | None | None |
2013-02-01 | Malfunction | None | Device Slipped |
2013-02-01 | Injury | None | None |
2013-01-28 | Injury | None | Break |
2013-01-04 | Death | None | None |
2013-01-01 | Malfunction | None | Inflation Problem |
2013-01-01 | Malfunction | None | Air Leak, Break |
2012-11-07 | Malfunction | None | None |
2012-09-30 | Malfunction | None | None |
2012-08-22 | Injury | None | None |
2012-06-27 | Malfunction | None | None |
2012-05-24 | Death | None | None |
2012-04-15 | Injury | None | None |
2011-11-02 | Malfunction | None | None |
2011-05-28 | Malfunction | None | None |
2011-05-11 | Malfunction | None | None |
2011-04-27 | Injury | None | None |
2010-05-14 | Malfunction | None | None |
2010-05-12 | Injury | None | None |
2010-04-15 | Malfunction | None | None |
2010-03-24 | Injury | None | None |
2010-02-12 | Injury | None | None |
2010-01-25 | Malfunction | None | None |
2009-12-31 | Malfunction | None | None |
2009-07-20 | Malfunction | None | None |