FDA Adverse Event
Malfunction
Summary report: N
AFFINITY 4 BIRTHING BED
MDR report key: 3101728
·
Received April 30, 2013
Report
- Report Number
- 1824206-2013-02423
- Event Type
- Malfunction
- Date Received
- April 30, 2013
- Date of Event
- April 5, 2013
- Report Date
- April 5, 2013
- Manufacturer
- HILL-ROM, INC.
- Product Code
- HDD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO FURTHER INFORMATION IS AVAILABLE ON THE REPAIR OF THE BED AT THIS TIME.
Description of Event or Problem · 1
THE ACCOUNT ALLEGED THE FOOT SECTION OF THE BED WOULD RUN UP WHEN WEIGHT WAS APPLIED. NO PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 186928 | AFFINITY 4 BIRTHING BED | BIRTHING BED | HDD | HILL-ROM, INC. | 3700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |