MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-09-02 for LIFEPAK 5 0900285953 NA manufactured by Unknown.
[12777]
Pt found in cardiopulmonary arrest, icu/ccu code team responded. Pt was defibrillated using lifepak 5. When the pt was defibrillated the pt sustained this occurred during three of the five attempts to defibrillate. Pt expired - unrelated to defibrillation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 19709 |
| MDR Report Key | 19709 |
| Date Received | 1994-09-02 |
| Date of Report | 1994-08-19 |
| Date of Event | 1994-07-17 |
| Date Facility Aware | 1994-08-18 |
| Report Date | 1994-08-19 |
| Date Reported to FDA | 1994-08-19 |
| Date Added to Maude | 1995-02-14 |
| 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 | LIFEPAK 5 |
| Generic Name | DEFIBRILLATOR |
| Product Code | DRK |
| Date Received | 1994-09-02 |
| Model Number | 0900285953 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 12 YR |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 19613 |
| Manufacturer | UNKNOWN |
| Manufacturer Address | 11811 WILLOWS ROAD REDMOND WA 98052 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1994-09-02 |