FDA Adverse Event
Malfunction
Summary report: N
AFFINITY BED
MDR report key: 2063142
·
Received March 16, 2011
Report
- Report Number
- 1824206-2011-01629
- Event Type
- Malfunction
- Date Received
- March 16, 2011
- Date of Event
- June 9, 2008
- Report Date
- June 9, 2008
- Manufacturer
- HILL-ROM, INC.
- Product Code
- HDD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN ADJUSTED THE BRAKE AND STEER CASTERS TO RESOLVE THE ISSUE. THIS MDR IS A RESULT OF CAPA ACTIVITY FOR THE RETROSPECTIVE REVIEW OF COMPLAINTS.
Description of Event or Problem · 1
TECHNICIAN ALLEGED THE BRAKES WERE NOT FUNCTIONING PROPERLY. NO INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AFFINITY BED | BIRTHING BED | HDD | HILL-ROM, INC. | 3600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |