MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-08 for BARIATRIC BED manufactured by Medline.
[102245990]
Facility mgmt where pt resides reported pt fall on (b)(6) 2018 was a result of equipment malfunction related to bariatric bed and mattress. Facility where pt resides reported on (b)(6) 2018 concerns that bariatric bed / mattress in use by pt, caused the pt fall on (b)(6) 2018 resulting in bruise to his forehead and two skin tears to bilateral lower extremities. Facility staff reports that the overlaying vinyl mattress is not safely secure on bariatric bed creating fall risk if pt repositions in bed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7331365 |
| MDR Report Key | 7331365 |
| Date Received | 2018-03-08 |
| Date of Report | 2018-03-06 |
| Date of Event | 2018-02-02 |
| Date Facility Aware | 2018-02-27 |
| Report Date | 2018-03-06 |
| Date Reported to FDA | 2018-03-06 |
| Date Reported to Mfgr | 2018-02-20 |
| Date Added to Maude | 2018-03-12 |
| 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 | 3 |
| 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 | BARIATRIC BED |
| Generic Name | BARI BED |
| Product Code | OSI |
| Date Received | 2018-03-08 |
| Returned To Mfg | 2018-02-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | NA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-08 |