MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-16 for PROGRESSA FRAME P7500A000131 manufactured by Hill-rom Batesville.
[114218809]
The hill-rom technician found the external alarm needed to be replaced. The external alarm is the source of the brake not set alarm. It is necessary for the progressa? Bed to have an effective maintenance program. We recommend that you do annual preventive maintenance. Examine the brakes to see whether the bed moves when the brakes are set. Replace as necessary. Examine the steering mechanism. Replace or adjust the steering control elements of the steering caster if necessary. Replace the caster if necessary. Troubleshoot in the event of a malfunction. A search of the hill-rom maintenance records did not show hill-rom performed any preventative maintenance on this bed. It is unknown if the facility performs preventative maintenance on their beds. The technician replaced the external alarm to resolve the issue. Based on this information, no further action is required.
Patient Sequence No: 1, Text Type: N, H10
[114218870]
Hill-rom received a report from a hill-rom technician stating the bed had no audible alarm. 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 | 1824206-2018-00272 |
| MDR Report Key | 7690912 |
| Date Received | 2018-07-16 |
| Date of Report | 2018-07-03 |
| Date of Event | 2018-07-03 |
| Date Mfgr Received | 2018-07-03 |
| Device Manufacturer Date | 2013-08-20 |
| Date Added to Maude | 2018-07-16 |
| 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 | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| 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 | PROGRESSA FRAME |
| Generic Name | BED, FLOTATION THERAPY, POWERED |
| Product Code | IOQ |
| Date Received | 2018-07-16 |
| Model Number | P7500A000131 |
| 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 | 2018-07-16 |