MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-12-22 for HOVERMATT manufactured by .
[16540382]
Patient on excel care es bariatric bed with hovermatt deflated under patient. Patient was sleeping and reported when she woke up her leg slide out of bed and her entire body slide on floor. Patient had 3 side rails up and hovermatt was under her on floor. Patient yelled for help and staff found her on floor. Reference mfr # 2531468-2014-00001.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4449591 |
| MDR Report Key | 4449591 |
| Date Received | 2014-12-22 |
| Date of Report | 2014-12-09 |
| Date of Event | 2014-11-20 |
| Date Facility Aware | 2014-11-20 |
| Report Date | 2014-12-09 |
| Date Added to Maude | 2015-01-27 |
| 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 | 0 |
| 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 | HOVERMATT |
| Generic Name | DEVICE, PATIENT TRANSFER, POWERED |
| Product Code | FRZ |
| Date Received | 2014-12-22 |
| Device Age | DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2014-12-22 |