MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-20 for DRIVE 15021BV manufactured by Unknown.
[106087238]
(b)(4) is the initial importer of the device which is a half bed rail. This bed rail was paired initially paired with an invacare mattress. The end-user was coded to hospice care. A new third party service provider for hospice care delivered a drive air mattress model 14027 to replace the invacare mattress. The delivery was supposed to include a peri cover that did not arrive with the mattress. No other changes were made to the setup. Per summons, despite noticing a new mattress, the staff did not perform a new bed rail safety assessment. It was reported that patient was immobile and incontinent. The next morning the patient was found entrapped between the mattress and the rail.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2438477-2018-00016 |
| MDR Report Key | 7447936 |
| Date Received | 2018-04-20 |
| Date of Report | 2018-04-17 |
| Date of Event | 2016-08-06 |
| Date Facility Aware | 2017-08-09 |
| Report Date | 2018-04-20 |
| Date Reported to FDA | 2018-04-20 |
| Date Added to Maude | 2018-04-20 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | 3 |
| Brand Name | DRIVE |
| Generic Name | HALF BED RAIL |
| Product Code | FNJ |
| Date Received | 2018-04-20 |
| Model Number | 15021BV |
| Operator | NURSING ASSISTANT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2018-04-20 |