FDA Adverse Event
Malfunction
Summary report: N
AFFINITY BED
MDR report key: 1132290
·
Received August 22, 2008
Report
- Report Number
- 1824206-2008-03186
- Event Type
- Malfunction
- Date Received
- August 22, 2008
- Date of Event
- July 31, 2008
- Report Date
- July 31, 2008
- Manufacturer
- HILL-ROM RITTER
- Product Code
- HDD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE FACILITY'S ENGINEER REPLACED THE SIDECOM CIRCUIT BOARD TO REPAIR THE BED.
Description of Event or Problem · 1
ALLEGEDLY, THE NURSE CALL WILL NOT WORK ON THE BED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AFFINITY BED | BIRTHING BED | HDD | HILL-ROM RITTER | 3601 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |