MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-04 for DRIVE MEDICAL 13222L manufactured by Drive Devilbiss Healthcare.
[96694165]
On (b)(6) 2017 at approximately 11:55 am two cnas were transferring a resident from their bed to her electric wheelchair via a bariatric mechanical lift when two of the nylon straps on the lift sling broke from the sling and the resident rolled sideways to the floor approximately 4 feet from the ground. The straps on the lift separated from the sling perfectly straight across the ribbing along the stitching that connects the straps to the sling. The sling appeared to have no other cosmetic defects. The resident was in a bariatric lift sling that was appropriate for their weight. The cnas reported that prior to placing the lift under the resident, they did not see any issues with the lift pad.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5074418 |
| MDR Report Key | 7168597 |
| Date Received | 2018-01-04 |
| Date of Report | 2018-01-03 |
| Date of Event | 2017-12-26 |
| Date Added to Maude | 2018-01-05 |
| 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 |
| 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 | DRIVE MEDICAL |
| Generic Name | FULL BODY SLING |
| Product Code | FNG |
| Date Received | 2018-01-04 |
| Model Number | 13222L |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DRIVE DEVILBISS HEALTHCARE |
| Manufacturer Address | PORT WASHINGTON NY 11050 US 11050 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-01-04 |