MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-02 for CLINITRON RITEHITE C-8 ASSY P0800010019 manufactured by Hill-rom Batesville.
[101658116]
The hill-rom technician found the brake caster needed to be replaced. Per the hill-rom user manual, warning: patients may use the bed for support while entering or exiting; if the unit moves unexpectedly, patient injury could occur. When the unit is unattended, ensure that both brakes are locked. The brakes for the clinitron bed are located at the right, head end and the left, foot end of the unit. To apply the brakes, step on the lower end of the brake lever to lock the wheels. To release the brakes, apply inward pressure to the upper end of the brake lever. The technician replaced the clinitron bed with an envella bed and scrapped the clinitron bed out of service to resolve the issue. Based on this information, no further action is required.
Patient Sequence No: 1, Text Type: N, H10
[101658117]
Hill-rom received a report from the account stating the left foot brake caster of the bed would not hold. 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 | 1824206-2018-00102 |
| MDR Report Key | 7310652 |
| Date Received | 2018-03-02 |
| Date of Report | 2018-02-16 |
| Date of Event | 2018-02-16 |
| Date Mfgr Received | 2018-02-16 |
| Date Added to Maude | 2018-03-02 |
| 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 | 2018-03-02 |
| 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 | 2018-03-02 |