FDA Adverse Event
Malfunction
Summary report: N
AFFINITY 4
MDR report key: 2222442
·
Received July 14, 2011
Report
- Report Number
- 1824206-2011-03741
- Event Type
- Malfunction
- Date Received
- July 14, 2011
- Date of Event
- June 30, 2011
- Report Date
- June 30, 2011
- Manufacturer
- HILL-ROM, INC.
- Product Code
- HDD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECH FOUND THE BRAKE WAS STICKING AND HE HAD TO MOVE PEDAL AROUND TO GET THE BRAKE TO DISENGAGE. HE FOUND THE BRAKE DETENT WAS CRACKED. HE REPLACED THE BRAKE DETENT TO REPAIR THE BED.
Description of Event or Problem · 1
INFO RECEIVED INDICATES THE BRAKE WILL NOT DISENGAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AFFINITY 4 | BIRTHING BED | HDD | HILL-ROM, INC. | 3700B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |