FDA Adverse Event
Malfunction
Summary report: N
AFFINITY THREE BIRTHING BED
MDR report key: 3221373
·
Received July 1, 2013
Report
- Report Number
- 1824206-2013-03284
- Event Type
- Malfunction
- Date Received
- July 1, 2013
- Date of Event
- February 25, 2013
- Report Date
- February 25, 2013
- Manufacturer
- HILL-ROM, INC.
- Product Code
- HDD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN REPLACED THE BRAKE CASTERS AND THE BRAKE DETENT MECHANISM TO RESOLVE THE ISSUE.
Description of Event or Problem · 1
THE TECHNICIAN ALLEGED THE BRAKES ARE SETTING BUT WOULD SWIVEL WHEN PUSHED FROM THE SIDE. NO INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 297236 | AFFINITY THREE BIRTHING BED | BIRTHING BED | HDD | HILL-ROM, INC. | 3700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |