MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-12-13 for CARDIAC FIBRILLATOR 310C * manufactured by Peter Schiff Enterprise.
[15539186]
The fibrillator pad was placed directly on the patient's heart by the md. The pad was properly connected to the fibrillator device by the rn, and then turned to full power at the md's request. No power was delivered to the pad, although, the output test light came on. We changed out the pad and tried the device again, but there was still no power delivered to the pad. The connections were checked with no response to the change. We were not able to fibrillate the patient using the fibrillator. We had to cool to fibrillate. Biomed verified the problem with the fibrillator.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1567150 |
| MDR Report Key | 1567150 |
| Date Received | 2009-12-13 |
| Date of Report | 2009-12-13 |
| Date of Event | 2009-11-17 |
| Report Date | 2009-12-13 |
| Date Reported to FDA | 2009-12-13 |
| Date Added to Maude | 2009-12-31 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | CARDIAC FIBRILLATOR |
| Generic Name | FIBRILLATOR, AC |
| Product Code | LIW |
| Date Received | 2009-12-13 |
| Returned To Mfg | 2009-12-08 |
| Model Number | 310C |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | 5 MO |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PETER SCHIFF ENTERPRISE |
| Manufacturer Address | 4900 FORREST HILL ROAD COOKEVILLE TN 38506 US 38506 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-12-13 |