MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-27 for CLINITRON RITEHITE C-8 ASSY P0800010019 manufactured by Hill-rom Batesville.
[128608670]
The hill-rom technician found the patient hand pendant needed to be replaced. Per the hill-rom user manual: powered bed mechanisms can cause serious injury. Operate the bed only with persons clear of moving bed surfaces. If you are trying to access a hydraulic function from the control panel or pendant and the unit is not operating properly, the following message may appear: head position sensors not calibrated. Notify hill-rom a search of the hill-rom maintenance records showed hill-rom performed preventative maintenance on this bed in september 2018. It is unknown if the facility performed any other preventative maintenance on this bed. 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
[128608671]
Hill-rom received a report from the account stating the bed head function is lowering on its own. The bed was located in room 1021 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 | 1824206-2018-00448 |
| MDR Report Key | 8107547 |
| Date Received | 2018-11-27 |
| Date of Report | 2018-11-13 |
| Date of Event | 2018-11-13 |
| Date Mfgr Received | 2018-11-13 |
| Device Manufacturer Date | 2013-11-04 |
| Date Added to Maude | 2018-11-27 |
| 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 | SHAWN FLANNERY |
| Manufacturer Street | 1069 STATE ROUTE 46 EAST |
| Manufacturer City | BATESVILLE IN 47006 |
| Manufacturer Country | US |
| Manufacturer Postal | 47006 |
| Manufacturer Phone | 8129313362 |
| 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 | 2018-11-27 |
| 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 | 2018-11-27 |