FDA Adverse Event
Malfunction
Summary report: N
AFFINITY 4
MDR report key: 1981292
·
Received February 2, 2011
Report
- Report Number
- 1824206-2011-00611
- Event Type
- Malfunction
- Date Received
- February 2, 2011
- Date of Event
- January 10, 2011
- Report Date
- January 14, 2011
- Manufacturer
- HILL-ROM, INC.
- Product Code
- HDD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN REPLACED THE BRAKE DETENT TO REPAIR THE BED.
Description of Event or Problem · 1
INFORMATION REC'D INDICATES, ONE CASTER WHEEL IS LOCKED AND WILL NOT MOVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AFFINITY 4 | BIRTHING BED | HDD | HILL-ROM, INC. | 3700B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |