FDA Adverse Event
Malfunction
Summary report: N
ADVANCE BED
MDR report key: 2020114
·
Received March 10, 2011
Report
- Report Number
- 1824206-2011-01407
- Event Type
- Malfunction
- Date Received
- March 10, 2011
- Date of Event
- April 4, 2008
- Report Date
- April 4, 2008
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TECHNICIAN FOUND THAT THE REVERSE TRENDELENBURG SWITCH WAS OUT OF ADJUSTMENT. THE TECHNICIAN ADJUSTED THE TRENDELENBURG SWITCH TO RESOLVE THE ISSUE. THIS MDR IS A RESULT OF A CAPA ACTIVITY FOR THE RETROSPECTIVE REVIEW OF COMPLAINTS.
Description of Event or Problem · 1
TECHNICIAN ALLEGED THAT THE BED WOULD NOT GO INTO REVERSE TRENDELENBURG. NO INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ADVANCE BED | A/C POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | 1130 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |