FDA Adverse Event
Malfunction
Summary report: N
CENTRA BED
MDR report key: 2050461
·
Received March 15, 2011
Report
- Report Number
- 1824206-2011-01582
- Event Type
- Malfunction
- Date Received
- March 15, 2011
- Date of Event
- December 3, 2008
- Report Date
- December 3, 2008
- Manufacturer
- HILL-ROM INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN COULD NOT ADJUST THE BRAKES AND FOUND THE BRAKE CABLE WAS STRETCHED. THE TECHNICIAN REPLACED THE BRAKE MECHANISM BLOCK TO RESOLVE THE ISSUE. THIS MDR IS A RESULT OF CAPA ACTIVITY FOR THE RETROSPECTIVE REVIEW OF COMPLAINTS.
Description of Event or Problem · 1
ACCOUNT ALLEGED THAT THE BRAKE CASTERS WERE NOT HOLDING IN BRAKE MODE. NO INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CENTRA BED | A/C POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM INC. | 850 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |