FDA Adverse Event
Malfunction
Summary report: N
AFFINITY BIRTHING BED
MDR report key: 2860366
·
Received November 5, 2012
Report
- Report Number
- 1824206-2012-07130
- Event Type
- Malfunction
- Date Received
- November 5, 2012
- Date of Event
- July 29, 2009
- Report Date
- July 29, 2009
- Manufacturer
- HILL-ROM, INC.
- Product Code
- HDD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN ISOLATED THE ISSUE TO THE CASTERS BEING OUT OF ADJUSTMENT. HE ADJUSTED THE BRAKE CASTERS TO REPAIR THE BED.
Description of Event or Problem · 1
INFORMATION RECEIVED INDICATES THE BRAKE IS NOT HOLDING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AFFINITY BIRTHING BED | BIRTHING BED | HDD | HILL-ROM, INC. | 3600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |