MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-04 for COMPELLA CAP US SCALE PD PPM P7800A000001 manufactured by Hill-rom Batesville.
[129589741]
The hill-rom technician found the patient control board assembly needed to be replaced. It is necessary for the compella? Bariatric bed system to have an effective maintenance program. We recommend that you do annual preventive maintenance.?? Specified checks:?? All caregiver and patient controls, along with their indicators, operate correctly; this includes controls for bed articulation, width extend and retract, scale, bed exit, surface functions, nurse call, cpr, foot longer and shorter, pendant controls, etc. Note: the communication cable that connects the asu to the bed frame must be fully connected and the four thumbscrews tightened for the powered width controls to operate. The motors operate correctly: during articulation, there is no friction, abnormal noises, or an audible indication of overload. A search of the hill-rom maintenance records showed hill-rom performed preventative maintenance on this bed in 2018. It is unknown if the facility performed any other preventative maintenance on this bed. The technician replaced the patient control board assembly to resolve the issue. Based on this information, no further action is required.
Patient Sequence No: 1, Text Type: N, H10
[129589743]
Hill-rom received a report from the account stating the head of the bed was going up on its own. 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 | 1824206-2018-00464 |
| MDR Report Key | 8130267 |
| Date Received | 2018-12-04 |
| Date of Report | 2018-11-15 |
| Date of Event | 2018-11-15 |
| Date Mfgr Received | 2018-11-15 |
| Device Manufacturer Date | 2016-06-27 |
| Date Added to Maude | 2018-12-04 |
| 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 | EMILY MITCHELL |
| Manufacturer Street | 1069 STATE ROUTE 46 EAST |
| Manufacturer City | BATESVILLE IN 47006 |
| Manufacturer Country | US |
| Manufacturer Postal | 47006 |
| Manufacturer Phone | 8129310130 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | COMPELLA CAP US SCALE PD PPM |
| Generic Name | BARIATRIC BED |
| Product Code | OSI |
| Date Received | 2018-12-04 |
| Model Number | P7800A000001 |
| 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 | 2018-12-04 |