MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-21 for VERSACARE BED 3200 manufactured by Hill-rom Batesville.
[23863654]
The hill-rom technician found the external alarm was faulty for this device. Per the hill-rom user manual, warning: the bed exit alarm system is not intended as a substitute for good nursing practices. The bed exit alarm system must be used in conjunction with a sound risk assessment and protocol. Per the hill-rom user manual, if the bed exit alarm does not arm and all three mode indicators are flashing, remove the patient and zero the bed exit system. 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
[23863655]
Hill-rom received a report from the account stating the bed alarm had no sound. 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 | 1824206-2015-00832 |
| MDR Report Key | 5020854 |
| Date Received | 2015-08-21 |
| Date of Report | 2015-08-03 |
| Date of Event | 2015-08-03 |
| Date Mfgr Received | 2015-08-03 |
| Device Manufacturer Date | 2013-11-21 |
| 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 |
| 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 | VERSACARE BED |
| Generic Name | A/C POWERED ADJUSTABLE HOSPITAL BED |
| Product Code | FNK |
| Date Received | 2015-08-21 |
| Model Number | 3200 |
| 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 | 2015-08-21 |