FDA Adverse Event
Malfunction
Summary report: N
AFFINITY
MDR report key: 2151381
·
Received June 8, 2011
Report
- Report Number
- 1824206-2011-03123
- Event Type
- Malfunction
- Date Received
- June 8, 2011
- Date of Event
- June 3, 2011
- Report Date
- June 3, 2011
- Manufacturer
- HILL-ROM INC.
- Product Code
- HDD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN REPLACED THE CASTERS TO RESOLVE THE ISSUE.
Description of Event or Problem · 1
INFO RECEIVED INDICATES THE BRAKES ON THE STEER CASTERS WOULD LOCK BUT STILL ALLOW THE CASTER TO SWIVEL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AFFINITY | BIRTHING BED | HDD | HILL-ROM INC. | 3600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |