MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-10-10 for ART OF CARE RECLINER 9080 manufactured by Hill-rom, Inc..
[16878452]
Info received indicated the brake caster is broken and will not hold.
Patient Sequence No: 1, Text Type: D, B5
[16949270]
The tech replaced the brake caster to repair the chair.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1824206-2012-06334 |
| MDR Report Key | 2823777 |
| Report Source | 07 |
| Date Received | 2012-10-10 |
| Date of Report | 2012-09-20 |
| Date of Event | 2012-09-20 |
| Date Mfgr Received | 2012-09-20 |
| Device Manufacturer Date | 2010-06-01 |
| Date Added to Maude | 2012-11-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARK VORNHEDER |
| Manufacturer Street | 1069 STATE RT 46 E |
| Manufacturer City | BATESVILLE IN 47006 |
| Manufacturer Country | US |
| Manufacturer Postal | 47006 |
| Manufacturer Phone | 8129347163 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ART OF CARE RECLINER |
| Generic Name | CHAIR, ADJUSTABLE, MECHANICAL |
| Product Code | FRJ |
| Date Received | 2012-10-10 |
| Model Number | 9080 |
| Operator | OTHER |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HILL-ROM, INC. |
| Manufacturer Address | 1069 STATE RT 46 E BATESVILLE IN 47006 US 47006 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-10-10 |