FDA Adverse Event
Malfunction
Summary report: N
AFFINITY THREE BIRTHING BED
MDR report key: 3060492
·
Received March 25, 2013
Report
- Report Number
- 1824206-2013-01659
- Event Type
- Malfunction
- Date Received
- March 25, 2013
- Date of Event
- February 25, 2013
- Report Date
- February 25, 2013
- Product Code
- HDD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE HILL-ROM TECHNICIAN REPLACED THE CASTERS TO RESOLVE THE ISSUE.
Description of Event or Problem · 1
INFO RECEIVED INDICATED THE CASTERS WOULD SWIVEL IN BRAKE MODE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 121274 | AFFINITY THREE BIRTHING BED | BIRTHING BED | HDD | 3700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |