MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-20 for CAREASSIST BED CA100 1170 manufactured by Hill-rom France.
[23862816]
The hill-rom technician found the brakes were not holding due to three brake casters, one steer caster, and four caster supports damaged. 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. Brake casters should be checked for cuts, wear and quality of tread, etc. And replaced when necessary. Check the brakes to see whether the bed moves when the brake pedals are pressed and repair as necessary. A search of the hill-rom maintenance records showed hill-rom performed preventative maintenance on this bed in 2012-2015. It is unknown if the facility performed any other preventative maintenance on this bed. The technician replaced the brake casters, one steer caster, and four caster supports to resolve the issue. Based on this information, no further action is required.
Patient Sequence No: 1, Text Type: N, H10
[23862817]
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 | 9615739-2015-00250 |
| MDR Report Key | 5018309 |
| Date Received | 2015-08-20 |
| Date of Report | 2015-07-30 |
| Date of Event | 2015-07-30 |
| Date Mfgr Received | 2015-07-30 |
| Date Added to Maude | 2015-08-20 |
| 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 | JOHN CUMMINGS |
| Manufacturer Street | 1069 STATE ROUTE 46 EAST |
| Manufacturer City | BATESVILLE IN 47006 |
| Manufacturer Country | US |
| Manufacturer Postal | 47006 |
| Manufacturer Phone | 8129312869 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CAREASSIST BED CA100 |
| Generic Name | A/C POWERED ADJUSTABLE HOSPITAL BED |
| Product Code | FNK |
| Date Received | 2015-08-20 |
| Model Number | 1170 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 | 2015-08-20 |