FDA Adverse Event
Malfunction
Summary report: N
AFFINITY BED
MDR report key: 1250884
·
Received December 2, 2008
Report
- Report Number
- 1824206-2008-04436
- Event Type
- Malfunction
- Date Received
- December 2, 2008
- Date of Event
- November 3, 2008
- Report Date
- November 3, 2008
- Manufacturer
- HILL-ROM RITTER
- Product Code
- HDD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN REPLACED THE GAS SPRINGS TO REPAIR THE BED.
Description of Event or Problem · 1
INFO RECEIVED INDICATES THE TRENDELENBURG FUNCTION IS NOT WORKING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AFFINITY BED | BIRTHING BED | HDD | HILL-ROM RITTER | 3600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |