FDA Adverse Event
Malfunction
Summary report: N
AFFINITY 4
MDR report key: 1070231
·
Received June 30, 2008
Report
- Report Number
- 1824206-2008-02620
- Event Type
- Malfunction
- Date Received
- June 30, 2008
- Date of Event
- December 13, 2007
- Report Date
- December 13, 2007
- Manufacturer
- HILL-ROM RITTER
- Product Code
- HDD
- Removal / Correction Number
- Z-0617-2008
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADJUSTED THE CASTERS TO REPAIR THE BED. MOD 373 IS A FIELD CORRECTIVE ACTION WHICH REPLACES THE BRAKE DETENT MECHANISM AND ADJUSTS ALL FOUR CASTERS OF THE AFFINITY 4 BIRTHING BED. THIS FAILURE OCCURRED FOLLOWING THE CORRECTION OF THIS UNIT.
Description of Event or Problem · 1
ALLEGED WHEN PUSHING AND PULLING THE BED, THE BRAKE WILL RELEASE.
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 |