MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-09 for ART OF CARE RECLINER P9080B0000965-2 manufactured by Hill-rom Batesville.
[144699324]
The hill-rom technician found the casters needed to be replaced. Per the hill-rom service manual recommends semi-annual function and cosmetic checks to make sure the product remains in good working order. The function check should include inspecting assembly fasteners and tightening as needed. If the recliner has a gas spring, check for proper function and adjust as needed. A search of the hill-rom maintenance records did not show hill-rom performed any preventative maintenance on this unit. It is unknown if the facility performs preventative maintenance on their units. The technician replaced the casters to resolve the issue. Based on this information, no further action is required.
Patient Sequence No: 1, Text Type: N, H10
[144699325]
Hill-rom received a report from a hill-rom service technician stating the brakes were not holding. The unit was located at the account. There was no patient/user injury reported. This report was filed in our complaint handling system as (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1824206-2019-00193 |
| MDR Report Key | 8595500 |
| Date Received | 2019-05-09 |
| Date of Report | 2019-04-26 |
| Date of Event | 2019-04-26 |
| Date Mfgr Received | 2019-04-26 |
| Device Manufacturer Date | 2008-06-23 |
| Date Added to Maude | 2019-05-09 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | EMILY MITCHELL |
| Manufacturer Street | 1069 STATE ROUTE 46 EAST |
| Manufacturer City | BATESVILLE IN 47006 |
| Manufacturer Country | US |
| Manufacturer Postal | 47006 |
| Manufacturer Phone | 8129310130 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ART OF CARE RECLINER |
| Generic Name | CHAIR AND TABLE, MEDICAL |
| Product Code | KMN |
| Date Received | 2019-05-09 |
| Model Number | P9080B0000965-2 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HILL-ROM BATESVILLE |
| Manufacturer Address | 1069 STATE ROUTE 46 EAST BATESVILLE IN 47006 US 47006 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-09 |