MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-08-16 for PHYSIO-CONTROL DEF.-LIFEPAK 8 PAD.-800505-03 NONE manufactured by Physio-control.
[2621]
Lifepak defibrillator cassette - paramedics arrived at scene at 2324, pt with gun shot wound to heart. Pt in full arrest - cpr began. Pt arrived to hospital at 2339 in full arrest: cpr in progress - at 0012 - life pak used, defib paddles used, lifepak did not charge, defib paddles not labelled by manufacturer for use. Only with lifepak. Paddles fit both machines. Pt did not recover - coroner's casedevice not labeled for single use. Patient medical status prior to event: invalid data. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-jul-93. Service provided by: user facility biomedical/bioengineering department. Service records available. No imminent hazard to public health claimed. Device not used as labeled/indended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, electrical tests performed, performance tests performed, visual examination. Results of evaluation: other. Conclusion: other. Certainty of device as cause of or contributor to event: no. Corrective actions: other. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6322 |
| MDR Report Key | 6322 |
| Date Received | 1993-08-16 |
| Date of Report | 1993-07-19 |
| Date of Event | 1993-07-10 |
| Date Facility Aware | 1993-07-10 |
| Report Date | 1993-07-19 |
| Date Reported to FDA | 1993-07-19 |
| Date Reported to Mfgr | 1993-07-15 |
| Date Added to Maude | 1993-08-31 |
| 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 | PHYSIO-CONTROL |
| Generic Name | DEFIBRILLATOR & ANTERIOR POSTERIOR PADDLES |
| Product Code | DRK |
| Date Received | 1993-08-16 |
| Model Number | DEF.-LIFEPAK 8 PAD.-800505-03 |
| Catalog Number | NONE |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Device Age | 01-SEP-86 |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 6011 |
| Manufacturer | PHYSIO-CONTROL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 1993-08-16 |