MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-08-31 for PHYSIO CONTROL LIFE PAK 9P 805460-01 manufactured by Physio Control Corporation.
[17441120]
Patient presented tothe emergency room in full cardiac arrest. Defibrillator was utilized and failed to discharge electrical current. It was immediately replaced with another defibrillator, which discharged appropriately.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 10104 |
| MDR Report Key | 10104 |
| Date Received | 1993-08-31 |
| Date of Report | 1993-06-16 |
| Date of Event | 1993-06-13 |
| Date Facility Aware | 1993-06-13 |
| Report Date | 1993-06-16 |
| Date Reported to Mfgr | 1993-06-13 |
| Date Added to Maude | 1993-09-15 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PHYSIO CONTROL |
| Generic Name | DEFIBRILLATOR/MONITOR AND PACER |
| Product Code | DRK |
| Date Received | 1993-08-31 |
| Returned To Mfg | 1993-06-14 |
| Model Number | LIFE PAK 9P |
| Catalog Number | 805460-01 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 36 MO |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 10104 |
| Manufacturer | PHYSIO CONTROL CORPORATION |
| Manufacturer Address | 11811 WILLOWS ROAD, NE REDMOND WA 98052 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1993-08-31 |