MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-12 for CHAIR, WITH CASTERS manufactured by Champion Manufacturing, Inc..
[57202359]
Patient Sequence No: 1, Text Type: N, H10
[57202360]
There are three reported incidents of tipping for the medical reclining chair/transporter with side table and foot rest, while in use by a patient. There was no patient injury. The weight limit in the specifications is 300 pounds. When a patient places their full weight on the retractable foot rest the chair tips forward lifting the back wheels off the floor about four inches.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6020463 |
| MDR Report Key | 6020463 |
| Date Received | 2016-10-12 |
| Date of Report | 2016-09-13 |
| Date of Event | 2016-08-29 |
| Report Date | 2016-09-13 |
| Date Reported to FDA | 2016-09-13 |
| Date Reported to Mfgr | 2016-09-13 |
| Date Added to Maude | 2016-10-12 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 |
| Generic Name | CHAIR, WITH CASTERS |
| Product Code | INM |
| Date Received | 2016-10-12 |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHAMPION MANUFACTURING, INC. |
| Manufacturer Address | 2601 INDUSTRIAL PKWY. ELKHART IN 46516 US 46516 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-12 |