MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-31 for CLINITRON RITEHITE C-8 ASSY P0800010019 manufactured by Hill-rom Batesville.
[119042258]
The hill-rom technician found the right hand pendant port was not functioning as intended. The technician moved the hand pendant to the left hand pendant port to resolve the issue. The right hand pendant port will be repaired at the conclusion of this rental period when the bed is not in use. Based on this information, no further action is required at this time.
Patient Sequence No: 1, Text Type: N, H10
[119042259]
Hill-rom received a report from the account stating the head of the bed was going up and down on its own (self run). 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 | 1824206-2018-00334 |
| MDR Report Key | 7837385 |
| Date Received | 2018-08-31 |
| Date of Report | 2018-08-08 |
| Date of Event | 2018-08-08 |
| Date Mfgr Received | 2018-08-08 |
| Date Added to Maude | 2018-08-31 |
| 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 | LORI DAULTON |
| Manufacturer Street | 1069 STATE ROUTE 46 EAST |
| Manufacturer City | BATESVILLE IN 47006 |
| Manufacturer Country | US |
| Manufacturer Postal | 47006 |
| Manufacturer Phone | 8129312280 |
| 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 | 2018-08-31 |
| 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 | 2018-08-31 |