FDA Adverse Event
Malfunction
Summary report: N
AFFINITY BED
MDR report key: 1991362
·
Received January 27, 2011
Report
- Report Number
- 1824206-2011-00513
- Event Type
- Malfunction
- Date Received
- January 27, 2011
- Date of Event
- January 5, 2011
- Report Date
- January 5, 2011
- Manufacturer
- HILL-ROM INC.
- Product Code
- HDD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN FOUND THE TREND GAS CYLINDERS WERE NOT WORKING. HE REPLACED THE TREND GAS CYLINDERS TO REPAIR THE BED.
Description of Event or Problem · 1
INFO RECEIVED INDICATES THE BED WILL NOT GO INTO TRENDELENBURG.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AFFINITY BED | BIRTHING BED | HDD | HILL-ROM INC. | 3601 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |