FDA Adverse Event
Malfunction
Summary report: N
CENTRA 850 BED CENTRA BED 3 MOTOR
MDR report key: 1666918
·
Received April 16, 2010
Report
- Report Number
- 1824206-2010-05925
- Event Type
- Malfunction
- Date Received
- April 16, 2010
- Date of Event
- May 1, 2008
- Report Date
- May 1, 2008
- Manufacturer
- HILL-ROM RITTER
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
TECHNICIAN CLEANED AND DEGREASED THE HILOW BRAKE ASSEMBLY 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 WILL NOT STAY IN HIGH POSITION, HILOW IS DRIFTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CENTRA 850 BED CENTRA BED 3 MOTOR | A/C POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM RITTER | P850 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |