FDA Adverse Event
Malfunction
Summary report: N
AFFINITY 4
MDR report key: 2133809
·
Received May 12, 2011
Report
- Report Number
- 1824206-2011-02680
- Event Type
- Malfunction
- Date Received
- May 12, 2011
- Date of Event
- April 20, 2011
- Report Date
- April 20, 2011
- Manufacturer
- HILL-ROM INC.
- Product Code
- HDD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN FOUND THE BRAKE DETENT WAS BROKEN. HE REPLACED THE BRAKE DETENT TO REPAIR THE BED.
Description of Event or Problem · 1
INFO REC'D INDICATES THE BRAKE IS NOT DISENGAGING.
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 |