MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-10 for POSEY PADS manufactured by Posey Products.
[70185892]
Burning smell noted upon entering room. Discovered sheet on bed alarm to be charred with a yellow color. The bed alarm pad was hot to the touch with a yellow charring area, and smelled like mechanical burning. A nurse walked into her patient's room and noticed a "burning" mechanical smell. She investigated and discovered that the poseyt elite bed pad that the patient had been laying on for less than 24 hours had "sparked" and burned the blanket under the patient. The bed alarm pad was "hot" to the touch and had a yellow charring area in the center of the pad (approximately 5 x 4 in size). There was no harm to the patient. Dates of use: (b)(6) 2017. Diagnosis or reason for use: prevent patient from falling.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5068495 |
| MDR Report Key | 6410575 |
| Date Received | 2017-03-10 |
| Date of Report | 2017-03-09 |
| Date of Event | 2017-02-28 |
| Date Added to Maude | 2017-03-16 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | POSEY PADS |
| Generic Name | POSEY ELITE BED PADS (BED ALARM) |
| Product Code | FNJ |
| Date Received | 2017-03-10 |
| Lot Number | 6251T007 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | POSEY PRODUCTS |
| Manufacturer Address | 5635 PECK ROAD ARCADIA CA 910060020 US 910060020 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-10 |