FDA Adverse Event
Malfunction
Summary report: N
AFFINITY BED
MDR report key: 2031560
·
Received March 21, 2011
Report
- Report Number
- 1824206-2011-01715
- Event Type
- Malfunction
- Date Received
- March 21, 2011
- Date of Event
- February 24, 2011
- Report Date
- February 24, 2011
- 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 ACCOUNT'S MAINTENANCE BELIEVES THE CASTERS ARE WORN FROM AGE. REPAIRS HAVE NOT BEEN COMPLETED.
Description of Event or Problem · 1
THE ACCOUNT ALLEGED WHEN THEY ENGAGE THE BRAKE PEDAL THE BRAKE DOES NOT HOLD IF THEY LEAN ON THE BED FRAME.
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 |