MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-07-19 for SAFHS manufactured by Exogen, Inc..
[20008]
A device failure was reported on 6/27/95. A replacement unit was sent to the pt on the same day in a priority overnight shipment. The problem was described to be that when the main operating unit (mou) "stand by" l. E. D. Would illuminate when the "treatment start" switch was depressed. This problem could not be duplicated by co on the returned unit. However, an intermittent alarm problem was traced to an overly large gap between the adaptor plate and treatment heal module (thm) housing. This was caused by a concave section in the thm housing. Corrective actions are being instituted that may prevent future occurrences.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5000011 |
| MDR Report Key | 28789 |
| Date Received | 1995-07-19 |
| Date of Report | 1995-07-18 |
| Date of Event | 1995-06-27 |
| 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 | 1995-07-19 |
| ID Number | P9000009/RC3U1 |
| Operator | OTHER |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 29756 |
| Manufacturer | EXOGEN, INC. |
| Manufacturer Address | 10 CONSTITUTION AVE PISCATAWAY NJ 08855 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1995-07-19 |