FDA Adverse Event
Malfunction
Summary report: N
AFFINITY 3
MDR report key: 2031557
·
Received March 21, 2011
Report
- Report Number
- 1824206-2011-01714
- Event Type
- Malfunction
- Date Received
- March 21, 2011
- Date of Event
- February 23, 2011
- Report Date
- February 23, 2011
- Manufacturer
- HILL-ROM, INC.
- Product Code
- HDD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE TECH REPLACED THE CAM POST TO REPAIR THE BED.
Description of Event or Problem · 1
INFO RECEIVED INDICATES, A WELD BROKE ON THE LEFT CAM POST.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AFFINITY 3 | BIRTHING BED | HDD | HILL-ROM, INC. | 3700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |