MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-11-29 for LIFE PAK 5 N/A manufactured by Physio Control.
[2728]
Patient was in cardiac arrest - emt's attempted to defibrillate life pak failed to charge x 2, then failed to dischaargeinvalid 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-feb-93. Service provided by: independent factory trained/authorized service organization. Service records available. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, electrical tests performed. Results of evaluation: electrical problem. Conclusion: device evaluated and alleged failure could not be duplicated. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device permanently removed from service, other. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5135 |
| MDR Report Key | 5135 |
| Date Received | 1993-04-27 |
| Date of Event | 1993-03-26 |
| Date Facility Aware | 1993-03-26 |
| Date Reported to Mfgr | 1993-04-02 |
| Date Added to Maude | 1993-06-29 |
| 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 PAK 5 |
| Generic Name | DEFIBRILLATOR |
| Product Code | DRK |
| Date Received | 1993-11-29 |
| Model Number | N/A |
| Catalog Number | N/A |
| Lot Number | N/A |
| ID Number | N/A |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | * |
| Device Sequence No | 1 |
| Device Event Key | 4837 |
| Manufacturer | PHYSIO CONTROL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 1993-04-27 |