MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-26 for TC BARIATRIC PLUS W/AIR & PULM P1840RE300 manufactured by Hill-rom Batesville.
[143981614]
The hill-rom technician found the patient left hand side rail needed to be repaired. The totalcare bariatric bed and totalcare bariatric plus therapy system require 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 bed function controls for proper operation of the function and momentary operation. Test all lockout controls and individually check for proper operation. The technician will repair the left hand side rail to resolve the issue. Based on this information, no further action is required.
Patient Sequence No: 1, Text Type: N, H10
[143981615]
Hill-rom received a report from the account stating the head section would self run up. 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 | 1824206-2019-00179 |
| MDR Report Key | 8556855 |
| Date Received | 2019-04-26 |
| Date of Report | 2019-04-15 |
| Date of Event | 2019-04-15 |
| Date Mfgr Received | 2019-04-15 |
| Device Manufacturer Date | 2006-11-09 |
| Date Added to Maude | 2019-04-26 |
| 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 | TC BARIATRIC PLUS W/AIR & PULM |
| Generic Name | BARIATRIC BED |
| Product Code | OSI |
| Date Received | 2019-04-26 |
| Model Number | P1840RE300 |
| 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 | 2019-04-26 |