FDA Adverse Event
Malfunction
Summary report: N
AFFINITY 4
MDR report key: 2151283
·
Received June 7, 2011
Report
- Report Number
- 1824206-2011-03138
- Event Type
- Malfunction
- Date Received
- June 7, 2011
- Date of Event
- May 13, 2011
- Report Date
- May 13, 2011
- Manufacturer
- HILL-ROM, INC.
- Product Code
- HDD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A NEW BRAKE DETENT ASSEMBLY WAS INSTALLED AND THE BRAKE FUNCTION IS WORKING PROPERLY.
Description of Event or Problem · 1
INFORMATION RECEIVED INDICATES THE BRAKE DETENT ASSEMBLY IS BROKEN AND THE BRAKES WILL 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 |