FDA Adverse Event
Malfunction
Summary report: N
REMANUFACTURED, REMANUFACTURED RETR
MDR report key: 1725518
·
Received June 9, 2010
Report
- Report Number
- 1824206-2010-08021
- Event Type
- Malfunction
- Date Received
- June 9, 2010
- Date of Event
- January 18, 2008
- Report Date
- January 18, 2008
- Manufacturer
- HILL-ROM INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
TECHNICIAN REPLACED THE LEFT HAND AND RIGHT HAND USER CONTROL MODULE CABLE ASSEMBLY AND THE RIGHT HAND POWER CONTROL BOARD 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 NO HEAD UP OR DOWN FUNCTIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REMANUFACTURED, REMANUFACTURED RETR | A/C POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM INC. | PR1900B004185 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |