MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-01 for BRAUNABILITY NCL919FID-2 manufactured by Braunability.
[54442350]
Mobility lift on van malfunction. The pressure plate that causes an audible alarm to sound and a visual light displayed did not sound or display during the time that the pt was being unloaded from the van with the lift in the down position. This resulted in the pt rolling in the wheelchair through the open back door with the lift on the ground and not in the proper elevated position. Because of this failure, the driver did not recognize that the lift was down, causing severe and life threatening injury to the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5064644 |
| MDR Report Key | 5939662 |
| Date Received | 2016-09-01 |
| Date of Report | 2016-09-01 |
| Date of Event | 2016-08-31 |
| Date Added to Maude | 2016-09-09 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | BRAUNABILITY |
| Generic Name | MOBILITY LIFT |
| Product Code | PCE |
| Date Received | 2016-09-01 |
| Model Number | NCL919FID-2 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BRAUNABILITY |
| Manufacturer Address | WINAMAC IN 46996 US 46996 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Other; 4. Deathisabilit | 2016-09-01 |