MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-02 for HILL-ROM VERSACARE A.I.R. BED P3200 manufactured by Hill-rom, Inc..
[173951791]
Following a patient fall that resulted in injury, it was identified that the bed alarm was not working. Upon further examination by the biomedical technician, the bed alarm sound board stopped working resulting in the alarm not functioning as designed. There was no visible damage to the board, no cracks or problem noted. The manufacturer was contacted for support in repair/replacement. The installation date of the unit was march 25, 2014. Fda safety report id (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092005 |
| MDR Report Key | 9540634 |
| Date Received | 2020-01-02 |
| Date of Report | 2019-12-31 |
| Date of Event | 2019-09-20 |
| Date Added to Maude | 2020-01-02 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | RISK MANAGER |
| 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 | HILL-ROM VERSACARE A.I.R. BED |
| Generic Name | BED, FLOTATION THERAPY, POWERED |
| Product Code | IOQ |
| Date Received | 2020-01-02 |
| Model Number | P3200 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HILL-ROM, INC. |
| Manufacturer Address | BATESVILLE IN 47006 US 47006 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-02 |