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 | Pneumonia | 1 | Patient |
| 2024 | Insufficient Information | 9 | Patient |
| 2024 | Hypoxia | 1 | Patient |
| 2024 | Dyspnea | 1 | Patient |
| 2024 | Burn(s) | 1 | Patient |
| 2024 | Use of Device Problem | 1 | Device |
| 2024 | Unexpected Shutdown | 8 | Device |
| 2024 | Unable to Obtain Readings | 40 | Device |
| 2024 | Patient Device Interaction Problem | 2 | Device |
| 2024 | Pacing Problem | 12 | Device |
| 2024 | No Display/Image | 29 | Device |
| 2024 | Mechanics Altered | 1 | Device |
| 2024 | Mechanical Problem | 2 | Device |
| 2024 | Grounding Malfunction | 19 | Device |
| 2024 | Failure to Power Up | 23 | Device |
| 2024 | Failure to Deliver Shock/Stimulation | 8 | Device |
| 2024 | Failure to Convert Rhythm | 1 | Device |
| 2024 | Failure to Charge | 2 | Device |
| 2024 | Failure to Capture | 3 | Device |
| 2024 | Failure of Device to Self-Test | 9 | Device |
| 2024 | Defibrillation/Stimulation Problem | 45 | Device |
| 2024 | Arcing of Electrodes | 1 | Device |
| 2024 | Activation Problem | 4 | Device |
| 2023 | Ventricular Fibrillation | 2 | Patient |
| 2023 | Tachycardia | 1 | Patient |
| 2023 | Necrosis | 2 | Patient |
| 2023 | Insufficient Information | 23 | Patient |
| 2023 | Injection Site Reaction | 1 | Patient |
| 2023 | Electric Shock | 1 | Patient |
| 2023 | Cardiomyopathy | 1 | Patient |
| 2023 | Use of Device Problem | 2 | Device |
| 2023 | Unintended Electrical Shock | 1 | Device |
| 2023 | Unexpected Shutdown | 11 | Device |
| 2023 | Unable to Obtain Readings | 79 | Device |
| 2023 | Sparking | 1 | Device |
| 2023 | Smoking | 1 | Device |
| 2023 | Self-Activation or Keying | 1 | Device |
| 2023 | Patient Device Interaction Problem | 1 | Device |
| 2023 | Pacing Problem | 26 | Device |
| 2023 | Output below Specifications | 1 | Device |
| 2023 | Output Problem | 9 | Device |
| 2023 | Noise, Audible | 1 | Device |
| 2023 | No Display/Image | 74 | Device |
| 2023 | Mechanics Altered | 1 | Device |
| 2023 | Mechanical Problem | 1 | Device |
| 2023 | Incorrect, Inadequate or Imprecise Result or Readings | 1 | Device |
| 2023 | Incorrect Interpretation of Signal | 1 | Device |
| 2023 | Inappropriate/Inadequate Shock/Stimulation | 1 | Device |
| 2023 | Inaccurate Synchronization | 3 | Device |
| 2023 | Grounding Malfunction | 50 | Device |
| 2023 | Failure to Power Up | 36 | Device |
| 2023 | Failure to Deliver Shock/Stimulation | 26 | Device |
| 2023 | Failure to Charge | 3 | Device |
| 2023 | Failure to Align | 1 | Device |
| 2023 | Failure of Device to Self-Test | 20 | Device |
| 2023 | Difficult to Interrogate | 1 | Device |
| 2023 | Defibrillation/Stimulation Problem | 82 | Device |
| 2023 | Arcing of Electrodes | 1 | Device |
| 2023 | Activation Problem | 3 | Device |
| 2022 | Necrosis | 1 | Patient |
| 2022 | Insufficient Information | 7 | Patient |
| 2022 | Burn(s) | 1 | Patient |
| 2022 | Use of Device Problem | 2 | Device |
| 2022 | Unintended Electrical Shock | 1 | Device |
| 2022 | Unexpected Shutdown | 7 | Device |
| 2022 | Unable to Obtain Readings | 60 | Device |
| 2022 | Self-Activation or Keying | 2 | Device |
| 2022 | Reset Problem | 4 | Device |
| 2022 | Power Problem | 1 | Device |
| 2022 | Patient Device Interaction Problem | 2 | Device |
| 2022 | Pacing Problem | 15 | Device |
| 2022 | Output Problem | 7 | Device |
| 2022 | No Display/Image | 60 | Device |
| 2022 | Mechanics Altered | 3 | Device |
| 2022 | Mechanical Problem | 4 | Device |
| 2022 | Incorrect Interpretation of Signal | 3 | Device |
| 2022 | Inappropriate/Inadequate Shock/Stimulation | 1 | Device |
| 2022 | Inaccurate Synchronization | 1 | Device |
| 2022 | Grounding Malfunction | 28 | Device |
| 2022 | Fire | 1 | Device |
| 2022 | Failure to Power Up | 41 | Device |
| 2022 | Failure to Deliver Shock/Stimulation | 19 | Device |
| 2022 | Failure to Charge | 5 | Device |
| 2022 | Failure to Analyze Signal | 2 | Device |
| 2022 | Failure of Device to Self-Test | 20 | Device |
| 2022 | Electrical Shorting | 1 | Device |
| 2022 | Electrical /Electronic Property Problem | 1 | Device |
| 2022 | Defibrillation/Stimulation Problem | 54 | Device |
| 2022 | Arcing of Electrodes | 1 | Device |
| 2022 | Activation Problem | 3 | Device |
| 2022 | Accessory Incompatible | 1 | Device |