SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
This device is manufactured by DATASCOPE CORP, GETINGE / DATASCOPE CORP, MAQUET, MAQUET CARDIOVASCULAR DATASCOPE CORP, MAQUET DATASCOPE.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Pain | 1 | Patient |
| 2024 | Low Blood Pressure/ Hypotension | 2 | Patient |
| 2024 | Intracranial Hemorrhage | 1 | Patient |
| 2024 | Insufficient Information | 109 | Patient |
| 2024 | Appropriate Term / Code Not Available | 3 | Patient |
| 2024 | Unexpected Shutdown | 27 | Device |
| 2024 | Unable to Obtain Readings | 2 | Device |
| 2024 | Suction Problem | 1 | Device |
| 2024 | Smoking | 1 | Device |
| 2024 | Shipping Damage or Problem | 1 | Device |
| 2024 | Retraction Problem | 7 | Device |
| 2024 | Restricted Flow rate | 2 | Device |
| 2024 | Pumping Stopped | 8 | Device |
| 2024 | Problem with Software Installation | 1 | Device |
| 2024 | Pressure Problem | 3 | Device |
| 2024 | Power Problem | 4 | Device |
| 2024 | Overheating of Device | 22 | Device |
| 2024 | Output Problem | 3 | Device |
| 2024 | Optical Problem | 5 | Device |
| 2024 | Obstruction of Flow | 1 | Device |
| 2024 | Noise, Audible | 10 | Device |
| 2024 | No Visual Prompts/Feedback | 1 | Device |
| 2024 | No Display/Image | 15 | Device |
| 2024 | No Device Output | 8 | Device |
| 2024 | Mechanical Problem | 2 | Device |
| 2024 | Mechanical Jam | 4 | Device |
| 2024 | Material Twisted/Bent | 1 | Device |
| 2024 | Material Integrity Problem | 12 | Device |
| 2024 | Material Frayed | 1 | Device |
| 2024 | Material Fragmentation | 1 | Device |
| 2024 | Manufacturing, Packaging or Shipping Problem | 1 | Device |
| 2024 | Low Readings | 2 | Device |
| 2024 | Loose or Intermittent Connection | 1 | Device |
| 2024 | Leak/Splash | 7 | Device |
| 2024 | Key or Button Unresponsive/not Working | 2 | Device |
| 2024 | Insufficient Information | 2 | Device |
| 2024 | Inflation Problem | 9 | Device |
| 2024 | Incorrect, Inadequate or Imprecise Result or Readings | 24 | Device |
| 2024 | Inappropriate or Unexpected Reset | 1 | Device |
| 2024 | Inadequate User Interface | 11 | Device |
| 2024 | Inability to Auto-Fill | 33 | Device |
| 2024 | Image Display Error/Artifact | 6 | Device |
| 2024 | Grounding Malfunction | 2 | Device |
| 2024 | Gas/Air Leak | 60 | Device |
| 2024 | Gas Output Problem | 2 | Device |
| 2024 | Fracture | 5 | Device |
| 2024 | Fluid/Blood Leak | 1 | Device |
| 2024 | False Positive Result | 2 | Device |
| 2024 | Failure to Zero | 1 | Device |
| 2024 | Failure to Transmit Record | 1 | Device |
| 2024 | Failure to Sense | 17 | Device |
| 2024 | Failure to Read Input Signal | 3 | Device |
| 2024 | Failure to Pump | 4 | Device |
| 2024 | Failure to Power Up | 16 | Device |
| 2024 | Failure to Charge | 24 | Device |
| 2024 | Failure to Calibrate | 3 | Device |
| 2024 | Erratic or Intermittent Display | 3 | Device |
| 2024 | Electrical /Electronic Property Problem | 1 | Device |
| 2024 | Display or Visual Feedback Problem | 17 | Device |
| 2024 | Difficult to Open or Close | 1 | Device |
| 2024 | Device Sensing Problem | 3 | Device |
| 2024 | Device Remains Activated | 1 | Device |
| 2024 | Device Handling Problem | 1 | Device |
| 2024 | Device Emits Odor | 3 | Device |
| 2024 | Device Displays Incorrect Message | 7 | Device |
| 2024 | Device Damaged Prior to Use | 1 | Device |
| 2024 | Device Contamination with Chemical or Other Material | 5 | Device |
| 2024 | Device Contamination with Body Fluid | 18 | Device |
| 2024 | Device Alarm System | 1 | Device |
| 2024 | Defective Component | 1 | Device |
| 2024 | Defective Alarm | 2 | Device |
| 2024 | Date/Time-Related Software Problem | 1 | Device |
| 2024 | Crack | 1 | Device |
| 2024 | Corroded | 1 | Device |
| 2024 | Connection Problem | 9 | Device |
| 2024 | Computer Software Problem | 1 | Device |
| 2024 | Complete Loss of Power | 1 | Device |
| 2024 | Communication or Transmission Problem | 6 | Device |
| 2024 | Circuit Failure | 3 | Device |
| 2024 | Charging Problem | 4 | Device |
| 2024 | Calibration Problem | 7 | Device |
| 2024 | Break | 41 | Device |
| 2024 | Battery Problem: Low Impedance | 1 | Device |
| 2024 | Battery Problem | 11 | Device |
| 2024 | Appropriate Term/Code Not Available | 55 | Device |
| 2023 | Pulmonary Embolism | 1 | Patient |
| 2023 | Myocardial Infarction | 1 | Patient |
| 2023 | Insufficient Information | 154 | Patient |
| 2023 | Heart Failure/Congestive Heart Failure | 1 | Patient |
| 2023 | Diminished Pulse Pressure | 1 | Patient |
| 2023 | Cardiomyopathy | 1 | Patient |
| 2023 | Appropriate Term / Code Not Available | 6 | Patient |
| 2023 | Vibration | 1 | Device |
| 2023 | Unexpected Shutdown | 10 | Device |
| 2023 | Temperature Problem | 1 | Device |
| 2023 | Tactile Prompts/Feedback | 1 | Device |
| 2023 | Separation Failure | 1 | Device |
| 2023 | Retraction Problem | 5 | Device |
| 2023 | Pumping Stopped | 2 | Device |
| 2023 | Pressure Problem | 3 | Device |
| 2023 | Premature Discharge of Battery | 3 | Device |
| 2023 | Power Problem | 4 | Device |
| 2023 | Positioning Problem | 1 | Device |
| 2023 | Overheating of Device | 14 | Device |
| 2023 | Output Problem | 5 | Device |
| 2023 | Optical Problem | 6 | Device |
| 2023 | Obstruction of Flow | 1 | Device |
| 2023 | Noise, Audible | 6 | Device |
| 2023 | No Visual Prompts/Feedback | 2 | Device |
| 2023 | No Pressure | 2 | Device |
| 2023 | No Display/Image | 11 | Device |
| 2023 | No Device Output | 4 | Device |
| 2023 | Missing Test Results | 2 | Device |
| 2023 | Missing Information | 1 | Device |
| 2023 | Mechanical Problem | 1 | Device |
| 2023 | Mechanical Jam | 1 | Device |
| 2023 | Material Separation | 2 | Device |
| 2023 | Material Integrity Problem | 4 | Device |
| 2023 | Material Frayed | 3 | Device |
| 2023 | Loose or Intermittent Connection | 2 | Device |
| 2023 | Leak/Splash | 13 | Device |
| 2023 | Insufficient Information | 1 | Device |
| 2023 | Inflation Problem | 1 | Device |
| 2023 | Incorrect, Inadequate or Imprecise Result or Readings | 32 | Device |
| 2023 | Inappropriate Waveform | 3 | Device |
| 2023 | Inadequate User Interface | 9 | Device |
| 2023 | Inability to Auto-Fill | 25 | Device |
| 2023 | Improper Flow or Infusion | 1 | Device |
| 2023 | Image Display Error/Artifact | 1 | Device |
| 2023 | Gas/Air Leak | 43 | Device |
| 2023 | Fracture | 2 | Device |
| 2023 | Fluid/Blood Leak | 1 | Device |
| 2023 | Failure to Zero | 5 | Device |
| 2023 | Failure to Transmit Record | 1 | Device |
| 2023 | Failure to Sense | 19 | Device |
| 2023 | Failure to Run on Battery | 1 | Device |
| 2023 | Failure to Read Input Signal | 1 | Device |
| 2023 | Failure to Power Up | 16 | Device |
| 2023 | Failure to Charge | 14 | Device |
| 2023 | Failure to Calibrate | 3 | Device |
| 2023 | Failure to Analyze Signal | 1 | Device |
| 2023 | Erratic or Intermittent Display | 10 | Device |
| 2023 | Energy Spectrum Incorrect | 1 | Device |
| 2023 | Display or Visual Feedback Problem | 7 | Device |
| 2023 | Display Difficult to Read | 2 | Device |
| 2023 | Difficult to Interrogate | 1 | Device |
| 2023 | Device Emits Odor | 1 | Device |
| 2023 | Device Displays Incorrect Message | 14 | Device |
| 2023 | Device Difficult to Maintain | 1 | Device |
| 2023 | Device Contamination with Chemical or Other Material | 4 | Device |
| 2023 | Device Contamination with Body Fluid | 13 | Device |
| 2023 | Device Alarm System | 4 | Device |
| 2023 | Detachment of Device or Device Component | 2 | Device |
| 2023 | Deformation Due to Compressive Stress | 1 | Device |
| 2023 | Deflation Problem | 1 | Device |
| 2023 | Decrease in Suction | 1 | Device |
| 2023 | Connection Problem | 5 | Device |
| 2023 | Component Incompatible | 1 | Device |
| 2023 | Communication or Transmission Problem | 4 | Device |
| 2023 | Coagulation in Device or Device Ingredient | 1 | Device |
| 2023 | Circuit Failure | 6 | Device |
| 2023 | Charging Problem | 1 | Device |
| 2023 | Capacitative Coupling | 1 | Device |
| 2023 | Calibration Problem | 5 | Device |
| 2023 | Break | 41 | Device |
| 2023 | Battery Problem | 7 | Device |
| 2023 | Backflow | 6 | Device |
| 2023 | Appropriate Term/Code Not Available | 50 | Device |
| 2023 | Application Program Problem | 2 | Device |
| 2023 | Application Program Freezes, Becomes Nonfunctional | 1 | Device |
| 2023 | Application Network Problem | 2 | Device |
| 2023 | Activation Failure | 1 | Device |
| 2023 | Accessory Incompatible | 1 | Device |
| 2022 | Insufficient Information | 22 | Patient |
| 2022 | Appropriate Term / Code Not Available | 2 | Patient |
| 2022 | Use of Device Problem | 1 | Device |
| 2022 | Unintended Application Program Shut Down | 1 | Device |
| 2022 | Unexpected Shutdown | 6 | Device |
| 2022 | Separation Failure | 1 | Device |
| 2022 | Retraction Problem | 2 | Device |
| 2022 | Pumping Stopped | 4 | Device |
| 2022 | Pressure Problem | 2 | Device |
| 2022 | Premature Discharge of Battery | 1 | Device |
| 2022 | Power Problem | 2 | Device |
| 2022 | Overheating of Device | 7 | Device |
| 2022 | Output Problem | 2 | Device |
| 2022 | Optical Problem | 4 | Device |
| 2022 | Noise, Audible | 6 | Device |
| 2022 | No Display/Image | 4 | Device |
| 2022 | No Device Output | 3 | Device |
| 2022 | Missing Test Results | 2 | Device |
| 2022 | Mechanical Problem | 1 | Device |
| 2022 | Material Rupture | 1 | Device |
| 2022 | Material Deformation | 1 | Device |
| 2022 | Loose or Intermittent Connection | 1 | Device |
| 2022 | Leak/Splash | 9 | Device |
| 2022 | Intermittent Loss of Power | 1 | Device |
| 2022 | Insufficient Information | 1 | Device |
| 2022 | Inflation Problem | 3 | Device |
| 2022 | Incorrect, Inadequate or Imprecise Result or Readings | 10 | Device |
| 2022 | Incomplete or Inadequate Connection | 1 | Device |
| 2022 | Inappropriate or Unexpected Reset | 1 | Device |
| 2022 | Inappropriate Waveform | 1 | Device |
| 2022 | Inability to Auto-Fill | 17 | Device |
| 2022 | Gas/Air Leak | 23 | Device |
| 2022 | Fracture | 1 | Device |
| 2022 | Fitting Problem | 1 | Device |
| 2022 | False Positive Result | 1 | Device |
| 2022 | Failure to Zero | 2 | Device |
| 2022 | Failure to Sense | 6 | Device |
| 2022 | Failure to Power Up | 10 | Device |
| 2022 | Failure to Charge | 13 | Device |
| 2022 | Failure to Calibrate | 2 | Device |
| 2022 | Erratic or Intermittent Display | 7 | Device |
| 2022 | Electrical /Electronic Property Problem | 1 | Device |
| 2022 | Display or Visual Feedback Problem | 8 | Device |
| 2022 | Disconnection | 2 | Device |
| 2022 | Device Sensing Problem | 1 | Device |
| 2022 | Device Fell | 1 | Device |
| 2022 | Device Emits Odor | 3 | Device |
| 2022 | Device Displays Incorrect Message | 15 | Device |
| 2022 | Device Dislodged or Dislocated | 1 | Device |
| 2022 | Device Contamination with Chemical or Other Material | 1 | Device |
| 2022 | Device Contamination with Body Fluid | 13 | Device |
| 2022 | Device Alarm System | 2 | Device |
| 2022 | Defective Component | 1 | Device |
| 2022 | Connection Problem | 4 | Device |
| 2022 | Computer Software Problem | 3 | Device |
| 2022 | Circuit Failure | 1 | Device |
| 2022 | Charging Problem | 1 | Device |
| 2022 | Calibration Problem | 1 | Device |
| 2022 | Break | 14 | Device |
| 2022 | Battery Problem | 5 | Device |
| 2022 | Backflow | 5 | Device |
| 2022 | Appropriate Term/Code Not Available | 36 | Device |
| 2022 | Application Program Freezes, Becomes Nonfunctional | 1 | Device |
| 2022 | Ambient Noise Problem | 1 | Device |
| 2021 | Insufficient Information | 6 | Patient |
| 2021 | Retraction Problem | 7 | Device |
| 2021 | Noise, Audible | 4 | Device |
| 2021 | Moisture or Humidity Problem | 3 | Device |
| 2021 | Moisture Damage | 1 | Device |
| 2021 | Mechanical Problem | 1 | Device |
| 2021 | Material Rupture | 2 | Device |
| 2021 | Material Integrity Problem | 4 | Device |
| 2021 | Manufacturing, Packaging or Shipping Problem | 1 | Device |
| 2021 | Leak/Splash | 2 | Device |
| 2021 | Installation-Related Problem | 1 | Device |
| 2021 | Incomplete or Missing Packaging | 1 | Device |
| 2021 | Inability to Auto-Fill | 1 | Device |
| 2021 | Display or Visual Feedback Problem | 3 | Device |
| 2021 | Device Fell | 2 | Device |
| 2021 | Device Displays Incorrect Message | 1 | Device |
| 2021 | Device Contamination with Body Fluid | 22 | Device |
| 2021 | Crack | 2 | Device |
| 2021 | Contamination of Device Ingredient or Reagent | 1 | Device |
| 2021 | Contamination | 2 | Device |
| 2021 | Break | 16 | Device |
| 2021 | Battery Problem | 1 | Device |
| 2021 | Backflow | 1 | Device |
| 2021 | Appropriate Term/Code Not Available | 14 | Device |
| 2020 | Insufficient Information | 4 | Patient |
| 2020 | Shipping Damage or Problem | 1 | Device |
| 2020 | Retraction Problem | 6 | Device |
| 2020 | Pumping Stopped | 1 | Device |
| 2020 | Power Problem | 1 | Device |
| 2020 | Noise, Audible | 4 | Device |
| 2020 | Mechanical Problem | 2 | Device |
| 2020 | Material Integrity Problem | 1 | Device |
| 2020 | Gas/Air Leak | 1 | Device |
| 2020 | Failure to Sense | 1 | Device |
| 2020 | Failure to Disconnect | 1 | Device |
| 2020 | Display or Visual Feedback Problem | 2 | Device |
| 2020 | Device Contamination with Chemical or Other Material | 2 | Device |
| 2020 | Device Contamination with Body Fluid | 11 | Device |
| 2020 | Component Missing | 1 | Device |
| 2020 | Component Incompatible | 2 | Device |
| 2020 | Break | 6 | Device |
| 2020 | Backflow | 1 | Device |
| 2020 | Appropriate Term/Code Not Available | 6 | Device |