MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-19 for TC BARIATRIC PLUS W/ AIR P1840RE200 manufactured by Hill-rom Batesville.
[127864813]
The hill-rom technician found the brake caster needed to be replaced. Per the hill-rom service manual, the totalcare? Bariatric bed and totalcare? Bariatric plus therapy system require an effective maintenance program. We recommend that you perform semi-annual preventive maintenance (pm) for joint commission certification. Pm not only meets joint commission requirements but can help make sure a long, operative life for the totalcare? Bariatric bed and totalcare? Bariatric plus therapy system. Pm will minimize downtime due to excessive wear. Inspect the casters for proper mounting, excessive wear, or tread damage. Replace as needed. Verify proper operation of the brake system. Adjust as necessary. A search of the hill-rom maintenance records showed hill-rom performed preventative maintenance on this bed in (b)(6) 2018. It is unknown if the facility performed any other preventative maintenance on this bed. The technician replaced the brake caster to resolve the issue. Based on this information, no further action is required.
Patient Sequence No: 1, Text Type: N, H10
[127864814]
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 | 1824206-2018-00440 |
| MDR Report Key | 8086289 |
| Date Received | 2018-11-19 |
| Date of Report | 2018-11-06 |
| Date of Event | 2018-10-27 |
| Date Mfgr Received | 2018-11-06 |
| Device Manufacturer Date | 2007-11-04 |
| Date Added to Maude | 2018-11-19 |
| 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 | 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 | TC BARIATRIC PLUS W/ AIR |
| Generic Name | BARIATRIC BED |
| Product Code | OSI |
| Date Received | 2018-11-19 |
| Model Number | P1840RE200 |
| 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 | 2018-11-19 |