MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-23 for COMPELLA CAP US SCALE PD PPM P7800A000001 manufactured by Hill-rom Batesville.
[134595155]
The hill-rom technical support representative performed troubleshooting over the phone with the account, asking the account to check the side comm board. 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: the communication cable and its connectors are in good condition. The sidecom communication system operates correctly. If any of these checks fail, repair or replace the part as applicable. 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 account replaced the side comm board to resolve the issue. Based on this information, no further action is required.
Patient Sequence No: 1, Text Type: N, H10
[134595156]
Hill-rom received a report from the account stating the nurse call was not working. 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 | 1824206-2019-00030 |
| MDR Report Key | 8271088 |
| Date Received | 2019-01-23 |
| Date of Report | 2019-01-03 |
| Date of Event | 2019-01-03 |
| Date Mfgr Received | 2019-01-03 |
| Date Added to Maude | 2019-01-23 |
| 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 | 2019-01-23 |
| Model Number | P7800A000001 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-01-23 |