LIFEPAK® 1000 DEFIBRILLATOR Adverse Event — Malfunction (MDR 0003015876-2020-00565)
LIFEPAK® 1000 DEFIBRILLATOR Adverse Event — Malfunction (MDR 0003015876-2020-00565) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: LIFEPAK® 1000 DEFIBRILLATOR; Generic name: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE); Manufacturer: PHYSIO-CONTROL, INC. - 3015876.
| Device | LIFEPAK® 1000 DEFIBRILLATOR |
|---|---|
| Generic name | AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) |
| Manufacturer | PHYSIO-CONTROL, INC. - 3015876 |
| Report number | 0003015876-2020-00565 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | USER FACILITY |
| Narrative | PHYSIO REPLACED THE DEVICE'S MEMBRANE SWITCH PANEL TO RESOLVE THE REPORTED ISSUE. PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. PHYSIO-CONTROL FURTHER EVALUATED THE REMOVED MEMBRANE SWITCH PANEL AND DETERMINED A SHORT CIRCUIT BETWEEN SOCKET 6 AND SOCKET 1 WAS THE CAUSE OF THE REPORTED ISSUE |
| Source | openFDA MAUDE (device adverse events) |
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