MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-22 for COMPELLA RENT US SCALE PD PPM P7800ARENT01 manufactured by Hill-rom Batesville.
[142751902]
The hill-rom technician found the air supply power cord had been pinched in the side rail, when it was lowered, and needed to be replaced. Per the hill-rom compella bariatric bed system user manual: warning? Before you plug the power cords in, make sure they are not damaged (cuts, exposed wires, worn insulation, etc. ). If either power cord is damaged, do not use the bed. Contact your facility-authorized maintenance person or hill-rom technical support. Warning? Incorrect use or handling of the power cords may cause damage to the power cords. If damage has occurred to either power cord or any of its components, immediately remove the bed from service, and contact your facility-authorized maintenance person or hill-rom technical support. The technician replaced the air supply power cord to resolve the issue. Based on this information, no further action is required.
Patient Sequence No: 1, Text Type: N, H10
[142751903]
Hill-rom received a report from the account stating the power cord for the air supply unit sparked and a flame could be seen. 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 | 1824206-2019-00173 |
| MDR Report Key | 8536709 |
| Date Received | 2019-04-22 |
| Date of Report | 2019-03-24 |
| Date of Event | 2019-03-24 |
| Date Mfgr Received | 2019-03-24 |
| Device Manufacturer Date | 2014-11-09 |
| Date Added to Maude | 2019-04-22 |
| 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 | TONY WERNER |
| Manufacturer Street | 1069 STATE ROUTE 46 EAST |
| Manufacturer City | BATESVILLE IN 47006 |
| Manufacturer Country | US |
| Manufacturer Postal | 47006 |
| Manufacturer Phone | 8129312359 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | COMPELLA RENT US SCALE PD PPM |
| Generic Name | BARIATRIC BED |
| Product Code | OSI |
| Date Received | 2019-04-22 |
| Model Number | P7800ARENT01 |
| 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 | 2019-04-22 |