MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-08-17 for SAFHS manufactured by Exogen, Inc..
[20888099]
A device failure was reported on 7/24/95. A replacement unit was sent to the pt on the same day. It was reported that when the power switch was turned on the fuse blew as did the replacement fuse. This occurred after thirty-three (33) treatments. Upon return of the unit it was found that the bridge rectifier was inoperative. This problem has not occurred since 1/95.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5000012 |
| MDR Report Key | 28791 |
| Date Received | 1995-08-17 |
| Date of Report | 1995-08-16 |
| Date of Event | 1995-07-24 |
| Date Added to Maude | 1995-12-19 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SAFHS |
| Generic Name | FRACTURE HEALING SYSTEM |
| Product Code | LPQ |
| Date Received | 1995-08-17 |
| ID Number | P900009/RC3U1 |
| Operator | OTHER |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 29758 |
| Manufacturer | EXOGEN, INC. |
| Manufacturer Address | 10 CONSTITUTION AVE PISCATAWAY NJ 08855 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1995-08-17 |