FDA Adverse Event
Malfunction
Summary report: N
AFFINITY THREE BIRTHING BED
MDR report key: 2983247
·
Received February 1, 2013
Report
- Report Number
- 1824206-2013-00848
- Event Type
- Malfunction
- Date Received
- February 1, 2013
- Date of Event
- January 22, 2013
- Report Date
- January 22, 2013
- Manufacturer
- HILL-ROM, INC.
- Product Code
- HDD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECH BENT THE SIDE RAIL BACK INTO THE CORRECT POSITION TO RESOLVE THE ISSUE.
Description of Event or Problem · 1
THE TECH ALLEGED THAT THE SIDE RAIL IS BENT AND WILL NOT LATCH. NO PT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 45272 | AFFINITY THREE BIRTHING BED | BIRTHING BED | HDD | HILL-ROM, INC. | 3700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |