MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-22 for LIFEPAK 15 MONITOR / DEFIBRILLATOR LP15 manufactured by Stryker.
[140126881]
Medical crew attempted to use the lp15 for defibrillation while pt was in cardiac arrest. The crew witnessed an apparent shock followed by the monitor turning non-responsive. An alternate machine was available and placed on the pt, replacing the lp15.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8457056 |
| MDR Report Key | 8457056 |
| Date Received | 2019-03-22 |
| Date of Report | 2019-03-22 |
| Date of Event | 2019-03-09 |
| Date Facility Aware | 2019-03-09 |
| Report Date | 2019-03-22 |
| Date Reported to Mfgr | 2019-03-09 |
| Date Added to Maude | 2019-03-27 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | LIFEPAK 15 MONITOR / DEFIBRILLATOR |
| Generic Name | MONITOR / DEFIBRILLATOR |
| Product Code | DRK |
| Date Received | 2019-03-22 |
| Model Number | LP15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 12 YR |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER |
| Manufacturer Address | REDMOND WA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2019-03-22 |