FDA Adverse Event
Malfunction
Summary report: N
AFFINITY BED
MDR report key: 1954549
·
Received December 15, 2010
Report
- Report Number
- 1824206-2010-11615
- Event Type
- Malfunction
- Date Received
- December 15, 2010
- Date of Event
- November 19, 2010
- Report Date
- November 19, 2010
- Manufacturer
- HILL-ROM, INC.
- Product Code
- HDD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECH TIGHTENED ALL OF THE GROUND SCREWS THAT SECURE GROUND WIRES TO THE BED. THE BED PASSED THE ELECTRICAL SAFETY TEST AFTER HE TIGHTENED THE SCREWS.
Description of Event or Problem · 1
THE TECH FOUND THAT THE GROUND RESISTANCE WAS TOO HIGH ON THE BED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AFFINITY BED | BIRTHING BED | HDD | HILL-ROM, INC. | 3600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |