AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
This device is manufactured by HEARTSINE TECHNOLOGIES, PHYSIO-CONTROL.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Cardiac Arrest | 1 | Patient |
| 2024 | Unexpected Shutdown | 3 | Device |
| 2024 | Key or Button Unresponsive/not Working | 2 | Device |
| 2024 | Incorrect Interpretation of Signal | 1 | Device |
| 2024 | Inappropriate/Inadequate Shock/Stimulation | 2 | Device |
| 2024 | Failure to Sense | 3 | Device |
| 2024 | Failure to Power Up | 18 | Device |
| 2024 | Failure to Charge | 1 | Device |
| 2024 | Failure to Analyze Signal | 1 | Device |
| 2024 | Energy Output Problem | 1 | Device |
| 2024 | Electrical /Electronic Property Problem | 14 | Device |
| 2024 | Device Sensing Problem | 2 | Device |
| 2023 | Myocardial Infarction | 1 | Patient |
| 2023 | Cardiac Arrest | 1 | Patient |
| 2023 | Unexpected Shutdown | 1 | Device |
| 2023 | Inappropriate/Inadequate Shock/Stimulation | 3 | Device |
| 2023 | Fracture | 1 | Device |
| 2023 | Failure to Sense | 3 | Device |
| 2023 | Failure to Power Up | 18 | Device |
| 2023 | Failure to Deliver Shock/Stimulation | 4 | Device |
| 2023 | Failure to Deliver Energy | 1 | Device |
| 2023 | Electrical /Electronic Property Problem | 18 | Device |
| 2023 | Display or Visual Feedback Problem | 1 | Device |
| 2023 | Defibrillation/Stimulation Problem | 1 | Device |
| 2023 | Connection Problem | 2 | Device |
| 2022 | Unexpected Shutdown | 6 | Device |
| 2022 | No Display/Image | 1 | Device |
| 2022 | Mechanical Problem | 1 | Device |
| 2022 | Key or Button Unresponsive/not Working | 1 | Device |
| 2022 | Incorrect Interpretation of Signal | 1 | Device |
| 2022 | Inappropriate/Inadequate Shock/Stimulation | 2 | Device |
| 2022 | Inappropriate Waveform | 1 | Device |
| 2022 | Failure to Sense | 4 | Device |
| 2022 | Failure to Power Up | 13 | Device |
| 2022 | Failure to Deliver Shock/Stimulation | 8 | Device |
| 2022 | Failure to Charge | 2 | Device |
| 2022 | Energy Output Problem | 1 | Device |
| 2022 | Electrical /Electronic Property Problem | 18 | Device |
| 2022 | Display or Visual Feedback Problem | 1 | Device |
| 2022 | Connection Problem | 3 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2021 | Failure to Power Up | 2 | Device |
| 2021 | Electrical /Electronic Property Problem | 2 | Device |