FDA Adverse Event
Malfunction
Summary report: N
AFFINITY 3 BED
MDR report key: 2922759
·
Received December 28, 2012
Report
- Report Number
- 1824206-2012-08711
- Event Type
- Malfunction
- Date Received
- December 28, 2012
- Date of Event
- December 17, 2012
- Report Date
- December 17, 2012
- 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 TO RESOLVE THIS ISSUE.
Description of Event or Problem · 1
THE TECHNICIAN ALLEGED THE BRAKE CASTERS ARE SETTING BUT WOULD SWIVEL WHEN PUSHED FROM THE SIDE. NO PT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AFFINITY 3 BED | BIRTHING BED | HDD | HILL-ROM, INC. | 3700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |