MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-11-05 for PHYSIO CONTROL 801380 manufactured by Physio Control.
[7899]
Facility alleges defibrillator failed to release current during cardiac arrest. Cpr done by staff until emt arrived. Patient was hospitalized. Reportedly in stable condition. The defibrillator was checked and replaced.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243621-1993-00191 |
| MDR Report Key | 10862 |
| Date Received | 1993-11-05 |
| Date of Report | 1993-10-22 |
| Date of Event | 1993-10-05 |
| Date Facility Aware | 1993-10-15 |
| Report Date | 1993-10-22 |
| Date Reported to FDA | 1993-10-22 |
| Date Reported to Mfgr | 1993-10-22 |
| Date Added to Maude | 1994-01-10 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | PHYSIO CONTROL |
| Generic Name | DEFIBRILLATOR |
| Product Code | DRK |
| Date Received | 1993-11-05 |
| Model Number | 801380 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 10862 |
| Manufacturer | PHYSIO CONTROL |
| Manufacturer Address | PO BOX 97006 REDMOND WA 98073 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 1993-11-05 |