FDA Adverse Event
Malfunction
Summary report: N
AFFINITY 3 BED
MDR report key: 2910733
·
Received December 4, 2012
Report
- Report Number
- 1824206-2012-07889
- Event Type
- Malfunction
- Date Received
- December 4, 2012
- Date of Event
- November 14, 2012
- Report Date
- November 14, 2012
- Manufacturer
- HILL-ROM, INC.
- Product Code
- HDD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN ADJUSTED THE BRAKE CASTERS TO RESOLVE THE ISSUE.
Description of Event or Problem · 1
THE TECHNICIAN ALLEGED THAT THE BRAKES ARE NOT HOLDING. NO PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AFFINITY 3 BED | BIRTHING BED | HDD | HILL-ROM, INC. | 3700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |