FDA Adverse Event
Malfunction
Summary report: N
AFFINITY 4
MDR report key: 1070242
·
Received June 30, 2008
Report
- Report Number
- 1824206-2008-02748
- Event Type
- Malfunction
- Date Received
- June 30, 2008
- Date of Event
- February 27, 2008
- Report Date
- February 27, 2008
- Manufacturer
- HILL-ROM RITTER
- Product Code
- HDD
- Removal / Correction Number
- Z-0617-2008
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE HILL-ROM FIELD INVESTIGATION INDICATED THE BRAKES WOULD NOT HOLD ON THE BED. THE TECHNICIAN FOUND THE BRAKE DETENT INSTALLED UPSIDE DOWN. THE BRAKE DETENT WAS INSTALLED IN THE CORRECT POSITION TO REPAIR THE BED.
Description of Event or Problem · 1
BRAKES WILL NOT HOLD ON THE BED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AFFINITY 4 | BIRTHING BED | HDD | HILL-ROM RITTER | 3700B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |