MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-21 for CARE ASSIST GENERIC P1170B manufactured by Hill-rom France.
[23922506]
Hill-rom technical support has paged a field technician to repair the bed. Per the hill-rom service manual the bed should be subject to an effective maintenance program. An annual service of the bed is advised in order to maintain its characteristics and performance. Head section motor: inspect the actuator assembly. Make sure the pins and retaining clips are intact and not missing. Fully raise and lower the head section. Make sure there is no friction or abnormal noises and that no audible overload indication can be heard during the movement. Repair as necessary. It is unknown if the facility performs preventative maintenance on their beds. 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
[23922507]
Hill-rom received a report from the account stating the head section would self-run when the bed is plugged in. 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 | 9615739-2015-00251 |
| MDR Report Key | 5020753 |
| Date Received | 2015-08-21 |
| Date of Report | 2015-07-30 |
| Date of Event | 2015-07-30 |
| Date Mfgr Received | 2015-07-30 |
| Date Added to Maude | 2015-08-21 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 | CARE ASSIST GENERIC |
| Generic Name | A/C POWERED ADJUSTABLE HOSPITAL BED |
| Product Code | FNK |
| Date Received | 2015-08-21 |
| Model Number | P1170B |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HILL-ROM FRANCE |
| Manufacturer Address | 188 RUE DU CADUCEE-PARC , EUROMEDECINE MONTPELLIER, HERAULT 34195 FR 34195 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-21 |