FDA Adverse Event
Malfunction
Summary report: N
AFFINITY BED
MDR report key: 2031576
·
Received March 21, 2011
Report
- Report Number
- 1824206-2011-01695
- Event Type
- Malfunction
- Date Received
- March 21, 2011
- Date of Event
- September 9, 2009
- Report Date
- September 9, 2009
- Manufacturer
- HILL-ROM, INC.
- Product Code
- HDD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
ACCOUNT 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
ACCOUNT ALLEGED THAT THE BRAKES WERE NOT LATCHING. NO PT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AFFINITY BED | BIRTHING BED | HDD | HILL-ROM, INC. | 3700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |