FDA Adverse Event
Malfunction
Summary report: N
AFFINITY 4
MDR report key: 2142584
·
Received June 21, 2011
Report
- Report Number
- 1824206-2011-03373
- Event Type
- Malfunction
- Date Received
- June 21, 2011
- Date of Event
- June 2, 2011
- Report Date
- June 2, 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 TECHNICIAN FOUND THE BRAKE DETENT WAS CRACKED AND BROKEN IN HALF. HE REPLACED THE BRAKE DETENT TO REPAIR THE BED. (B)(4) IS A FIELD CORRECTIVE ACTION WHICH REPLACES THE BRAKE DETENT MECHANISM. THIS IS A POST MOD FAILURE.
Description of Event or Problem · 1
INFO RECEIVED INDICATES THE BRAKE PEDAL WOULD GO INTO THE BRAKE POSITION BUT THE BRAKE CASTER WOULD NOT HOLD.
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 |