FDA Adverse Event
Malfunction
Summary report: N
ADVANCE 3000 ADVANCE FRAME
MDR report key: 1701831
·
Received May 21, 2010
Report
- Report Number
- 1824206-2010-07519
- Event Type
- Malfunction
- Date Received
- May 21, 2010
- Date of Event
- July 3, 2007
- Report Date
- July 3, 2007
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TECHNICIAN REPLACED THE BED EXIT TAPESWITCH, THE CAUTION LABELS AND THE POWERCORD STRAIN RELIEF TO RESOLVE THE ISSUE. 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 THAT THE BED HAD AN INTERMITTENT BED EXIT TAPESWITCH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ADVANCE 3000 ADVANCE FRAME | AC POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | P1155F54 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |