MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-27 for P500 MRS CONTROL UNIT P005787RENT02 manufactured by Hill-rom Batesville.
[131743900]
The hill-rom technician has picked up the unit for evaluation and repair. It is necessary for the p500 to have an effective maintenance program. We recommend that you do annual preventive maintenance. Control unit; make sure of these: the out of bed sensors operate correctly. Mattress assembly; make sure of these: the out of bed sensors and head of bed sensor mounting are not damaged. Repair or replace as necessary. A search of the hill-rom maintenance records showed hill-rom performed preventative maintenance on this unit in (b)(6) 2018. It is unknown if the facility performed any other preventative maintenance on this unit. No further information is available on the repair of the bed at this time. The investigation is ongoing, however if any additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[131743901]
Hill-rom received a report from the account stating the bed exit alarm was not working. 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 | 1824206-2018-00497 |
| MDR Report Key | 8200215 |
| Date Received | 2018-12-27 |
| Date of Report | 2018-11-30 |
| Date of Event | 2018-11-30 |
| Date Mfgr Received | 2018-11-30 |
| Device Manufacturer Date | 2010-08-12 |
| Date Added to Maude | 2018-12-27 |
| 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 | EMILY MITCHELL |
| Manufacturer Street | 1069 STATE ROUTE 46 EAST |
| Manufacturer City | BATESVILLE IN 47006 |
| Manufacturer Country | US |
| Manufacturer Postal | 47006 |
| Manufacturer Phone | 8129310130 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | P500 MRS CONTROL UNIT |
| Generic Name | BED, FLOTATION THERAPY, POWERED |
| Product Code | IOQ |
| Date Received | 2018-12-27 |
| Model Number | P005787RENT02 |
| 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 | 2018-12-27 |