FDA Adverse Event
Malfunction
Summary report: N
AFFINITY THREE BIRTHING BED
MDR report key: 3761334
·
Received January 2, 2014
Report
- Report Number
- 1824206-2014-00014
- Event Type
- Malfunction
- Date Received
- January 2, 2014
- Date of Event
- December 16, 2013
- Report Date
- December 16, 2013
- Manufacturer
- HILL-ROM, INC.
- Product Code
- HDD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN REPLACED THE SIDE RAIL POWER CONTROL BOARD ASSEMBLY TO RESOLVE THE ISSUE.
Description of Event or Problem · 1
THE TECHNICIAN ALLEGED THE HEAD OF THE BED RAISES ON ITS OWN. NO PT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 464 | AFFINITY THREE BIRTHING BED | BIRTHING BED | HDD | HILL-ROM, INC. | 3700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |