MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-01-11 for LIFE PACK 5 manufactured by Unknown.
[18449256]
Two attempts were made to defibrillate the patient - device failed to produce the needed shock/joules. 71 year old patient expired, but had been down in field for possibly 30 minutes prior to resusciatative efforts being initiated. Invalid data - regarding single use labeling of device. Patient medical status prior to event: critical condition. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-sep-93. Service provided by: invalid data. Service records available. Invalid data - regarding whether event presents imminent hazard. Invalid data - whether device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, performance tests performed. Results of evaluation: none or unknown. Conclusion: none or unknown. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: none or unknown. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7544 |
| MDR Report Key | 7544 |
| Date Received | 1994-01-11 |
| Date of Report | 1993-10-15 |
| Date of Event | 1993-10-09 |
| Date Facility Aware | 1993-10-09 |
| Report Date | 1993-10-15 |
| Date Reported to Mfgr | 1993-10-15 |
| Date Added to Maude | 1994-04-29 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIFE PACK 5 |
| Generic Name | DEFIBRILLATOR |
| Product Code | DRK |
| Date Received | 1994-01-11 |
| ID Number | 09-00285-08 09-00283-14 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 7223 |
| Manufacturer | UNKNOWN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 1994-01-11 |