MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2015-08-20 for VERSACARE FRAME 3200 manufactured by Hill-rom Batesville.
[23659156]
The hill-rom technician found the external alarm was faulty for this device. Per the hill-rom service manual, perform annual preventive maintenance procedures to make sure all versacare? Bed components are functioning as originally designed. Brake casters should be checked for cuts, wear and quality of tread, etc. And replaced when necessary. Examine the brakes to see whether the bed moves when the brake are set. Replace as necessary. A search of the hill-rom maintenance records did not show hill-rom performed any preventative maintenance on this bed. It is unknown if the facility performs preventative maintenance on their beds. The account replaced the external alarm to resolve the issue. Based on this information, no further action is required.
Patient Sequence No: 1, Text Type: N, H10
[23659157]
Hill-rom received a report from the account stating the brake not set alarm was inoperative. The bed was located at the account. There was no patient/user injury reported. This report was filed in our complaint handling system as complaint #(b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1824206-2015-00829 |
| MDR Report Key | 5018064 |
| Report Source | USER FACILITY |
| Date Received | 2015-08-20 |
| Date of Report | 2015-07-29 |
| Date of Event | 2015-07-29 |
| Date Mfgr Received | 2015-07-29 |
| Device Manufacturer Date | 2015-07-01 |
| Date Added to Maude | 2015-08-20 |
| 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 | JOHN CUMMINGS |
| Manufacturer Street | 1069 STATE ROUTE 46 EAST |
| Manufacturer City | BATESVILLE IN 47006 |
| Manufacturer Country | US |
| Manufacturer Postal | 47006 |
| Manufacturer Phone | 8129312869 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VERSACARE FRAME |
| Generic Name | A/C POWERED ADJUSTABLE HOSPITAL BED |
| Product Code | FNK |
| Date Received | 2015-08-20 |
| Model Number | 3200 |
| 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 | 2015-08-20 |