FDA Adverse Event
Malfunction
Summary report: N
AFFINITY 3
MDR report key: 2043325
·
Received March 15, 2011
Report
- Report Number
- 1824206-2011-01558
- Event Type
- Malfunction
- Date Received
- March 15, 2011
- Date of Event
- February 15, 2011
- Report Date
- February 15, 2011
- Manufacturer
- HILL-ROM, INC.
- Product Code
- HDD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN ADJUSTED THE BRAKE PEDAL TO REPAIR THE BED. THE PEDAL WAS NOT FULLY LOCKING.
Description of Event or Problem · 1
INFORMATION RECEIVED INDICATES THE BRAKE IS NOT WORKING CORRECTLY ON THE BED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AFFINITY 3 | BIRTHING BED | HDD | HILL-ROM, INC. | 3700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |