FDA Adverse Event
Malfunction
Summary report: N
AFFINITY THREE BIRTHING BED
MDR report key: 2923024
·
Received December 27, 2012
Report
- Report Number
- 1824206-2012-08589
- Event Type
- Malfunction
- Date Received
- December 27, 2012
- Date of Event
- December 11, 2012
- Report Date
- December 11, 2012
- Manufacturer
- HILL-ROM INC.
- Product Code
- HDD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN FOUND THAT THE TREND LINKAGE WAS NOT ADJUSTED PROPERLY. THE BED WOULD NOT STAY IN TREND HANDLES WERE ENGAGED BECAUSE THE CYLINDER DID NOT LOCK INTO POSITION. THE TECHNICIAN ADJUSTED THE TREND LINKAGE TO REPAIR THE BED.
Description of Event or Problem · 1
INFO REC'D INDICATES THE BED WILL NOT STAY IN THE TREND POSITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AFFINITY THREE BIRTHING BED | BIRTHING BED | HDD | HILL-ROM INC. | 3700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |