MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-11-28 for CHAIR SENTINEL 7800 * manufactured by Powderhorn Industries.
[20888126]
Resident had an auto alarm buckle belt attached to her w/c. When she removed alarm did not alarm. Possible short in wiring.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 135853 |
| MDR Report Key | 135853 |
| Date Received | 1997-11-28 |
| Date of Report | 1997-11-20 |
| Date of Event | 1997-11-15 |
| Date Added to Maude | 1997-12-05 |
| 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 |
| 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 | CHAIR SENTINEL |
| Generic Name | WHEELCHAIR ALARM |
| Product Code | KNO |
| Date Received | 1997-11-28 |
| Model Number | 7800 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 2.5 YR |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 132714 |
| Manufacturer | POWDERHORN INDUSTRIES |
| Manufacturer Address | PO BOX 1443 MONTROSE CO 81402 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-11-28 |