FDA Adverse Event
Malfunction
Summary report: N
AFFINITY BED
MDR report key: 2212885
·
Received July 12, 2011
Report
- Report Number
- 1824206-2011-03688
- Event Type
- Malfunction
- Date Received
- July 12, 2011
- Date of Event
- June 24, 2011
- Report Date
- June 24, 2011
- Manufacturer
- HILL-ROM, INC.
- Product Code
- HDD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN FOUND THE TREND GAS SPRINGS WERE NOT LOCKING, WHICH ALLOWED THE BED TO RETURN TO LEVEL. THE TECHNICIAN REPLACED THE TREND GAS SPRINGS TO REPAIR THE BED.
Description of Event or Problem · 1
INFORMATION RECEIVED INDICATES THE BED WILL NOT STAY IN THE TRENDELENBURG POSITION.
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 |