MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-31 for XL BARIATRIC BED PR610B manufactured by Hill-rom Batesville.
[119041478]
The hill-rom technician found the casters needed to be replaced. Per the hill-rom service manual it is necessary for the excel care? Bariatric bed to have an effective maintenance program. We recommend that you do annual preventive maintenance. Preventative maintenance will minimize downtime due to excessive wear. Examine the casters annually for cuts and wear. Repair or replace as necessary. Set the brakes. Make sure the bed does not move. Make sure the steering mechanism operates correctly. Repair or replace the brake and steer mechanism as necessary. A search of the hill-rom maintenance records showed hill-rom performed preventative maintenance on this bed in 2017. The technician will replace the casters to resolve the issue. Based on this information, no further action is required.
Patient Sequence No: 1, Text Type: N, H10
[119041479]
Hill-rom received a report from the account stating the brakes were not holding. The bed 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 | 1824206-2018-00335 |
| MDR Report Key | 7836971 |
| Date Received | 2018-08-31 |
| Date of Report | 2018-08-20 |
| Date of Event | 2018-08-20 |
| Date Mfgr Received | 2018-08-20 |
| Date Added to Maude | 2018-08-31 |
| 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 | TONY WERNER |
| Manufacturer Street | 1069 STATE ROUTE 46 EAST |
| Manufacturer City | BATESVILLE IN 47006 |
| Manufacturer Country | US |
| Manufacturer Postal | 47006 |
| Manufacturer Phone | 8129312359 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | XL BARIATRIC BED |
| Generic Name | BARIATRIC BED |
| Product Code | OSI |
| Date Received | 2018-08-31 |
| Model Number | PR610B |
| 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 | 2018-08-31 |