DEFIBRILLATOR/PACEMAKER
This device is manufactured by ZOLL MED CORP, ZOLL MEDICAL CORP, ZOLL MEDICAL CORPORATION, ZOLL MEDICAL CORPORATION WORLD WIDE HEADQUARTERS.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Ventricular Fibrillation | 2 | Patient |
| 2024 | Necrosis | 1 | Patient |
| 2024 | Insufficient Information | 20 | Patient |
| 2024 | Heart Block | 1 | Patient |
| 2024 | Electric Shock | 1 | Patient |
| 2024 | Chest Pain | 1 | Patient |
| 2024 | Cardiac Arrest | 22 | Patient |
| 2024 | Atrial Fibrillation | 1 | Patient |
| 2024 | Asystole | 2 | Patient |
| 2024 | Unintended Electrical Shock | 1 | Device |
| 2024 | Unexpected Shutdown | 16 | Device |
| 2024 | Unable to Obtain Readings | 43 | Device |
| 2024 | Reset Problem | 6 | Device |
| 2024 | Power Problem | 1 | Device |
| 2024 | Pacing Problem | 9 | Device |
| 2024 | Output below Specifications | 1 | Device |
| 2024 | Output above Specifications | 1 | Device |
| 2024 | No Display/Image | 39 | Device |
| 2024 | Incorrect Interpretation of Signal | 2 | Device |
| 2024 | Inappropriate/Inadequate Shock/Stimulation | 1 | Device |
| 2024 | Failure to Power Up | 59 | Device |
| 2024 | Failure to Deliver Shock/Stimulation | 15 | Device |
| 2024 | Failure to Charge | 9 | Device |
| 2024 | Failure to Capture | 1 | Device |
| 2024 | Failure to Analyze Signal | 2 | Device |
| 2024 | Failure of Device to Self-Test | 43 | Device |
| 2024 | Electromagnetic Interference | 1 | Device |
| 2024 | Electrical Shorting | 1 | Device |
| 2024 | Delayed Charge Time | 1 | Device |
| 2024 | Defibrillation/Stimulation Problem | 9 | Device |
| 2024 | Activation Problem | 5 | Device |
| 2023 | Ventricular Fibrillation | 2 | Patient |
| 2023 | Necrosis | 5 | Patient |
| 2023 | Insufficient Information | 35 | Patient |
| 2023 | Injection Site Reaction | 3 | Patient |
| 2023 | Chest Pain | 1 | Patient |
| 2023 | Cardiac Arrest | 7 | Patient |
| 2023 | Asthma | 1 | Patient |
| 2023 | Appropriate Term / Code Not Available | 1 | Patient |
| 2023 | Use of Device Problem | 6 | Device |
| 2023 | Unintended Power Up | 1 | Device |
| 2023 | Unintended Electrical Shock | 1 | Device |
| 2023 | Unexpected Shutdown | 18 | Device |
| 2023 | Unable to Obtain Readings | 83 | Device |
| 2023 | Self-Activation or Keying | 1 | Device |
| 2023 | Reset Problem | 15 | Device |
| 2023 | Pacing Problem | 20 | Device |
| 2023 | Output below Specifications | 1 | Device |
| 2023 | Noise, Audible | 1 | Device |
| 2023 | No Display/Image | 69 | Device |
| 2023 | Incorrect Interpretation of Signal | 3 | Device |
| 2023 | Gas/Air Leak | 1 | Device |
| 2023 | Failure to Power Up | 110 | Device |
| 2023 | Failure to Deliver Shock/Stimulation | 13 | Device |
| 2023 | Failure to Convert Rhythm | 1 | Device |
| 2023 | Failure to Charge | 12 | Device |
| 2023 | Failure to Capture | 2 | Device |
| 2023 | Failure to Analyze Signal | 4 | Device |
| 2023 | Failure of Device to Self-Test | 41 | Device |
| 2023 | Electrical Shorting | 4 | Device |
| 2023 | Electrical /Electronic Property Problem | 1 | Device |
| 2023 | Defibrillation/Stimulation Problem | 18 | Device |
| 2023 | Charging Problem | 1 | Device |
| 2023 | Activation Problem | 5 | Device |
| 2022 | Insufficient Information | 7 | Patient |
| 2022 | Use of Device Problem | 8 | Device |
| 2022 | Unintended Electrical Shock | 1 | Device |
| 2022 | Unexpected Shutdown | 15 | Device |
| 2022 | Unable to Obtain Readings | 71 | Device |
| 2022 | Sparking | 1 | Device |
| 2022 | Self-Activation or Keying | 1 | Device |
| 2022 | Reset Problem | 11 | Device |
| 2022 | Pacing Problem | 11 | Device |
| 2022 | Output Problem | 1 | Device |
| 2022 | No Display/Image | 62 | Device |
| 2022 | Mechanics Altered | 1 | Device |
| 2022 | Incorrect Interpretation of Signal | 1 | Device |
| 2022 | Grounding Malfunction | 1 | Device |
| 2022 | Failure to Power Up | 85 | Device |
| 2022 | Failure to Discharge | 1 | Device |
| 2022 | Failure to Deliver Shock/Stimulation | 12 | Device |
| 2022 | Failure to Convert Rhythm | 1 | Device |
| 2022 | Failure to Charge | 8 | Device |
| 2022 | Failure to Analyze Signal | 1 | Device |
| 2022 | Failure of Device to Self-Test | 36 | Device |
| 2022 | Electrical Shorting | 3 | Device |
| 2022 | Detachment of Device or Device Component | 1 | Device |
| 2022 | Delayed Charge Time | 1 | Device |
| 2022 | Defibrillation/Stimulation Problem | 13 | Device |
| 2022 | Battery Problem | 1 | Device |
| 2022 | Arcing of Electrodes | 1 | Device |
| 2022 | Activation Problem | 4 | Device |
| 2021 | Incorrect Interpretation of Signal | 1 | Device |