MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-07-12 for LIFE PAK 5 manufactured by Physio Control.
[15000]
Patient was in ventricular tach - was defibed at 200 j. V. Fib developed - defib @ 300 j. V. Fib continued - defibrillator (life pak 5) would not recharge 2 attemptsmade without success. Device not labeled for single use. 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: other. 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, performance tests performed. Results of evaluation: none or unknown. Conclusion: device failure occurred and was related to event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device returned to manufacturer/dealer/distributor. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 23040 |
| MDR Report Key | 23040 |
| Date Received | 1993-07-12 |
| Date of Report | 1993-02-12 |
| Date of Event | 1993-02-10 |
| Date Facility Aware | 1993-02-10 |
| Report Date | 1993-02-12 |
| Date Reported to Mfgr | 1993-02-10 |
| Date Added to Maude | 1995-06-13 |
| 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 |
| Generic Name | MONITOR/DEFIBRILLATOR |
| Product Code | DRK |
| Date Received | 1993-07-12 |
| Model Number | LIFE PAK 5 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 23279 |
| Manufacturer | PHYSIO CONTROL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1993-07-12 |