FDA Adverse Event
Malfunction
Summary report: N
AFFINITY 4
MDR report key: 1070262
·
Received June 30, 2008
Report
- Report Number
- 1824206-2008-02725
- Event Type
- Malfunction
- Date Received
- June 30, 2008
- Date of Event
- February 4, 2008
- Report Date
- February 4, 2008
- 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
THE HILL-ROM FIELD TECHNICIAN 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 BIRTHING BED. THIS FAILURE OCCURRED FOLLOWING THE CORRECTION OF THIS UNIT.
Description of Event or Problem · 1
BRAKE WILL DISENGAGE.
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 |