FDA Adverse Event
Malfunction
Summary report: N
AFFINITY IV BED
MDR report key: 2914970
·
Received December 7, 2012
Report
- Report Number
- 1824206-2012-07980
- Event Type
- Malfunction
- Date Received
- December 7, 2012
- Date of Event
- November 15, 2012
- Report Date
- November 15, 2012
- Manufacturer
- HILL-ROM, INC.
- Product Code
- HDD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECH REPLACED THE PT CONTROL BOARD TO RESOLVE THE ISSUE.
Description of Event or Problem · 1
THE TECH ALLEGED THAT THE HEAD OF THE BED IS GOING UP BY ITSELF. NO PT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AFFINITY IV BED | BIRTHING BED | HDD | HILL-ROM, INC. | 3700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |