FDA Adverse Event
Malfunction
Summary report: N
VERSACARE BED
MDR report key: 2051464
·
Received April 4, 2011
Report
- Report Number
- 1824206-2011-02003
- Event Type
- Malfunction
- Date Received
- April 4, 2011
- Date of Event
- March 10, 2011
- Report Date
- March 10, 2011
- Manufacturer
- HILL-ROM INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TECHNICIAN FOUND THE LEFT HEAD SIDE RAIL WAS DAMAGED MAKING IT UNABLE TO LOCK IN THE UPRIGHT POSITION. THE TECHNICIAN REPLACED THE DAMAGED MOUNTING BRACKET AND CENTER ARM ASSEMBLY ON THE LEFT HEAD SIDE RAIL TO RESOLVE THE ISSUE.
Description of Event or Problem · 1
TECHNICIAN ALLEGED THAT THE LEFT HEAD SIDE RAIL IS UNABLE TO LOCK IN THE UP POSITION. NO PT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VERSACARE BED | A/C POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM INC. | 3200 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |