FDA Adverse Event
Malfunction
Summary report: N
VERSACARE BED VERSACARE FRAME
MDR report key: 1780144
·
Received May 6, 2010
Report
- Report Number
- 1824206-2010-06896
- Event Type
- Malfunction
- Date Received
- May 6, 2010
- Date of Event
- May 8, 2008
- Report Date
- May 8, 2008
- Manufacturer
- HILL-ROM INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
TECHNICIAN REPAIRED THE BED EXIT SYSTEM TO RESOLVE THE ISSUE. NO FURTHER INFORMATION IS AVAILABLE ON THIS REPAIR. PURSUANT TO OUR RESPONSE TO WARNING LETTER 2008-DT-04, HILL-ROM IS CONTINUING ITS RETROSPECTIVE REVIEW OF EVENTS FOR REPORTABILITY. THIS EFFORT WILL CONTINUE UNTIL WE ARE CURRENT.
Description of Event or Problem · 1
TECHNICIAN ALLEGED THE BED EXIT WAS NOT FUNCTIONING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VERSACARE BED VERSACARE FRAME | A/C POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM INC. | P3200A000015 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |