FDA Adverse Event
Malfunction
Summary report: N
CENTRA 850 BED CENTRA BED 3 MOTOR
MDR report key: 1685670
·
Received May 3, 2010
Report
- Report Number
- 1824206-2010-06731
- Event Type
- Malfunction
- Date Received
- May 3, 2010
- Date of Event
- May 29, 2008
- Report Date
- May 29, 2008
- Manufacturer
- HILL-ROM RITTER
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
TECH REPAIRED THE HI/LOW DRIFT TO RESOLVE THE ISSUE. NO FURTHER INFO 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
TECH ALLEGED THAT THE HI/LOW WAS 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 |