SHILEY

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