MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-21 for REMAN TCB PLUS BED PR1840A000003 manufactured by Hill-rom Batesville.
[63332795]
The hill-rom technician found the brake casters needed to be replaced. Per the hill-rom service manual the totalcare bed system requires an effective maintenance program. We recommend that you perform a semi-annual preventative maintenance. Preventative maintenance will minimize downtime due to excessive wear. Test the brake casters to determine if the bed moves when you activate the brake, replace or adjust when necessary. Check the tires for cuts, wear, tread life, etc. A search of the hill-rom maintenance records showed hill-rom performed preventative maintenance on this bed in november 2016. It is unknown if the facility performed any other preventative maintenance on this bed. The hill-rom technician replaced the brake casters to resolve the issue. Based on this information, no further action is required.
Patient Sequence No: 1, Text Type: N, H10
[63332796]
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 complaint # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1824206-2016-00535 |
| MDR Report Key | 6192535 |
| Date Received | 2016-12-21 |
| Date of Report | 2016-11-30 |
| Date of Event | 2016-11-30 |
| Date Mfgr Received | 2016-11-30 |
| Device Manufacturer Date | 2007-07-24 |
| Date Added to Maude | 2016-12-21 |
| 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 | LORI DAULTON |
| Manufacturer Street | 1069 STATE ROUTE 46 EAST |
| Manufacturer City | BATESVILLE IN 47006 |
| Manufacturer Country | US |
| Manufacturer Postal | 47006 |
| Manufacturer Phone | 8129312280 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | REMAN TCB PLUS BED |
| Generic Name | BARIATRIC BED |
| Product Code | OSI |
| Date Received | 2016-12-21 |
| Model Number | PR1840A000003 |
| Operator | OTHER CAREGIVERS |
| 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 | 2016-12-21 |