MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-03-07 for SKIL CARE CHAIR PRO 909369 manufactured by Skil Care.
[807988]
Resident is confused. Resident stood up from wheel chair and fell to floor. Alarm did not sound to alert staff as it should have. Resident was in a supervised area.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5005820 |
| MDR Report Key | 1010226 |
| Date Received | 2008-03-07 |
| Date of Report | 2008-03-07 |
| Date of Event | 2008-01-18 |
| Date Added to Maude | 2008-03-17 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SKIL CARE CHAIR PRO |
| Generic Name | UNDER SEAT WHEEL CHAIR ALARM |
| Product Code | KNO |
| Date Received | 2008-03-07 |
| Model Number | 909369 |
| Catalog Number | 909369 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 980343 |
| Manufacturer | SKIL CARE |
| Manufacturer Address | 29 WELLS AVE YONKER NY 10701 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2008-03-07 |