FDA Adverse Event
Malfunction
Summary report: N
VERSACARE BED
MDR report key: 3474311
·
Received October 15, 2013
Report
- Report Number
- 1824206-2013-04648
- Event Type
- Malfunction
- Date Received
- October 15, 2013
- Date of Event
- September 18, 2013
- Report Date
- September 18, 2013
- Manufacturer
- PHILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO FURTHER INFO IS AVAILABLE ON THE REPAIR OF THE BED AT THIS TIME.
Description of Event or Problem · 1
THE ACCOUNT ALLEGED THE BED WILL NOT SEND AN ALARM TO THE NURSES' STATION. NO PT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 528757 | VERSACARE BED | A/C POWERED ADJUSTABLE HOSPITAL BED | FNL | PHILL-ROM, INC. | 3200 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |