FDA Adverse Event
Malfunction
Summary report: N
AFFINITY 4
MDR report key: 1112730
·
Received August 11, 2008
Report
- Report Number
- 1824206-2008-03061
- Event Type
- Malfunction
- Date Received
- August 11, 2008
- Date of Event
- July 21, 2008
- Report Date
- July 21, 2008
- Manufacturer
- HILL-ROM RITTER
- Product Code
- HDD
- Removal / Correction Number
- Z-0617-2008
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE HILL-ROM SERVICE TECH INVESTIGATED, AND FOUND THE BRAKES AND THE BED TO BE FUNCTIONING PROPERLY.
Description of Event or Problem · 1
BRAKE MIGRATING OUT OF THE LOCKED POSITION.
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 | UNK |