MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-25 for CLINITRON RITEHITE C-8 ASSY P0800010019 manufactured by Hill-rom Batesville.
[112315757]
The hill-rom technician found the hand pendant needed to be replaced. Per the hill-rom service manual, hand pendant malfunction: 1. Replace the hand pendant with a known good one, and test each of its functions. (rga the pendant removed from the unit. ) all functions operate normally with the new pendant. 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 hand pendant to resolve the issue. Based on this information, no further action is required.
Patient Sequence No: 1, Text Type: N, H10
[112315758]
Hill-rom received a report from the account stating the head of bed went up by itself. The bed was located at the account. There was no patient/user injury reported. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1824206-2018-00250 |
| MDR Report Key | 7635125 |
| Date Received | 2018-06-25 |
| Date of Report | 2018-05-26 |
| Date of Event | 2018-05-26 |
| Date Mfgr Received | 2018-05-26 |
| Device Manufacturer Date | 2007-05-29 |
| Date Added to Maude | 2018-06-25 |
| 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 | ERIN PADGETT |
| Manufacturer Street | 1069 STATE ROUTE 46 EAST |
| Manufacturer City | BATESVILLE IN 47006 |
| Manufacturer Country | US |
| Manufacturer Postal | 47006 |
| Manufacturer Phone | 8129312791 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CLINITRON RITEHITE C-8 ASSY |
| Generic Name | BED, AIR FLUIDIZED |
| Product Code | INX |
| Date Received | 2018-06-25 |
| Model Number | P0800010019 |
| 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 | 2018-06-25 |