MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-27 for COVE 53WH981U manufactured by Wieland Healthcare.
[106750065]
Patient Sequence No: 1, Text Type: N, H10
[106750066]
With orthopedic bariatric chair in locked position, upon patient pushing up to stand with left hand on armrest of chair, left side of chair began to slide. When weight is applied to one of the arms of the chair whether it is to stand up or sit down the chair has been known to slide away from the individual and could cause a patient to fall. The single locking mechanism does not lock all four wheels at the corners and it pivots on 2 wheels underneath the chair. Maintenance manager tried to get the chair to slide and was successful in his attempt. Two other members of the facilities maintenance team also caused it to slide as well. The manufacturer is wieland healthcare. Manufacturer response for reclining bariatric chair, recliner chair (per site reporter). Contacted (b)(6) at (b)(6). Setting up a meeting.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7468224 |
| MDR Report Key | 7468224 |
| Date Received | 2018-04-27 |
| Date of Report | 2018-03-28 |
| Date of Event | 2018-03-21 |
| Report Date | 2018-03-28 |
| Date Reported to FDA | 2018-03-28 |
| Date Reported to Mfgr | 2018-03-28 |
| Date Added to Maude | 2018-04-27 |
| 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 | 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 | COVE |
| Generic Name | CHAIR, WITH CASTERS |
| Product Code | INM |
| Date Received | 2018-04-27 |
| Model Number | 53WH981U |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WIELAND HEALTHCARE |
| Manufacturer Address | 10785 ROSE AVE NEW HAVEN IN 46774 US 46774 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-27 |