MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-02-28 for ART OF CARE RECLINER SEATING OPERA * manufactured by Hill-rom.
[17470453]
As the visitor released the lever which would allow the foot rest to open up, the foot rest collapsed on one side. It was noted that the brackets were loose which caused the foot rest to unhinge on one side. So far, we had five chairs with the same issue as described above. Each time the company has dispatched someone to the facility to repair the chairs on site. ====================== manufacturer response for reclining chair, art of care recliner seating opera======================we had this issue before with 5 chairs. A service representative was dispatched to repair the chairs each time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2004639 |
| MDR Report Key | 2004639 |
| Date Received | 2011-02-28 |
| Date of Report | 2011-02-25 |
| Date of Event | 2011-02-02 |
| Report Date | 2011-02-25 |
| Date Reported to FDA | 2011-02-28 |
| Date Added to Maude | 2011-03-02 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ART OF CARE RECLINER SEATING OPERA |
| Generic Name | RECLINING CHAIR |
| Product Code | FRJ |
| Date Received | 2011-02-28 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Age | 2 YR OLD |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HILL-ROM |
| Manufacturer Address | 1125 EAST PEARL ST. BATESVILLE IN 47006 US 47006 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-02-28 |