MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-08-17 for FERNO-WASHINGTON NI manufactured by Ferno Washington, Inc..
[100347]
Complainant is a medical officer for a fire department and is responsible for repair of medical equipment. The department has three backboards used for transportation of suspected spinal injury patients. The complainant reported that the backboards, which are made of polyurethane, are showing stress cracks and deformities in the plastic. He is concerned that the cracks could result in the boards not being able to carry their weight capacity. He stated that if users are unaware of the stress cracks, the problem could potentially result in a pt injury. He was also concerned that the stress cracks may be related to a mfg problem. The complainant stated that he has spoken with employees of an ambulance co who have also been experencing the same problems with these particular backboards. He stated that the boards were purchased some time in med 1996 and should not be showing this kind of problem. He plans to dispose of the boards.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4002312 |
| MDR Report Key | 182656 |
| Date Received | 1998-08-17 |
| Date of Report | 1998-07-13 |
| Date Added to Maude | 1998-08-19 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | FERNO-WASHINGTON |
| Generic Name | BACKBOARD |
| Product Code | FOA |
| Date Received | 1998-08-17 |
| Model Number | NI |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 177582 |
| Manufacturer | FERNO WASHINGTON, INC. |
| Manufacturer Address | 70 WEIL WAY WILMINGTON OH 45177 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-08-17 |