FDA Adverse Event
Malfunction
Summary report: N
AFFINITY 4
MDR report key: 1122605
·
Received August 20, 2008
Report
- Report Number
- 1824206-2008-00274
- Event Type
- Malfunction
- Date Received
- August 20, 2008
- Date of Event
- July 31, 2007
- Report Date
- July 31, 2007
- Manufacturer
- HILL-ROM RITTER
- Product Code
- HDD
- Removal / Correction Number
- 1824206-11/29/2007-003 C
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE HILL-ROM FIELD INVESTIGATION INDICATED THE BRAKES WOULD NOT HOLD ON THE BED. THE HILL-ROM FIELD TECHNICIAN ADJUSTED THE CASTERS TO REPAIR THE BED.
Description of Event or Problem · 1
ALLEGED THE BED WOULD "POP" OUT OF THE BRAKE POSITION WHEN THE BED WAS SHAKEN.
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 |