MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-03 for COMPELLA BARIATRIC BED P7800A manufactured by Hill-rom, Inc..
[88060799]
Patient Sequence No: 1, Text Type: N, H10
[88060800]
When the mattress topper is cleaned, the topper will overinflate and pop the surface creating a ballooning effect. Manufacturer response for bariatric bed system, compella (per site reporter): mfg states ballooning is due to cleaning with blower motor running.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6910545 |
| MDR Report Key | 6910545 |
| Date Received | 2017-10-03 |
| Date of Report | 2017-09-29 |
| Date of Event | 2017-04-01 |
| Report Date | 2017-09-29 |
| Date Reported to FDA | 2017-09-29 |
| Date Reported to Mfgr | 2017-09-29 |
| Date Added to Maude | 2017-10-03 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMPELLA BARIATRIC BED |
| Generic Name | BED, FLOTATION THERAPY, POWERED |
| Product Code | IOQ |
| Date Received | 2017-10-03 |
| Model Number | P7800A |
| Device Availability | * |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HILL-ROM, INC. |
| Manufacturer Address | 1069 STATE ROUTE 46 EAST BATESVILLE IN 47006 US 47006 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-03 |