MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-02 for COMPELLA AIR SUPPLY manufactured by Hill-rom, Inc..
[122332584]
A rental bed with lo-air loss pressure support mattress "were" brought into the patients room. The cord for the lo-air loss pressure mattress was pinched against the movable part of the bed frame. When the patient went to adjust the bed, the cord was compressed and caused the cord to spark and short. Manufacturer response for complella air supply, compella air supply (per site reporter): the rental manufacturer inspected the bed and verified it indeed had a crush/bruising that caused the power cord to short and spark.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7925415 |
| MDR Report Key | 7925415 |
| Date Received | 2018-10-02 |
| Date of Report | 2018-09-26 |
| Date of Event | 2018-08-19 |
| Report Date | 2018-09-26 |
| Date Reported to FDA | 2018-09-26 |
| Date Reported to Mfgr | 2018-10-02 |
| Date Added to Maude | 2018-10-02 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 AIR SUPPLY |
| Generic Name | BARIATRIC BED |
| Product Code | OSI |
| Date Received | 2018-10-02 |
| Returned To Mfg | 2018-08-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 7 DA |
| 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 | 2018-10-02 |