FDA Adverse Event
Malfunction
Summary report: N
AFFINITY 3
MDR report key: 2140596
·
Received June 16, 2011
Report
- Report Number
- 1824206-2011-03290
- Event Type
- Malfunction
- Date Received
- June 16, 2011
- Date of Event
- May 26, 2011
- Report Date
- May 26, 2011
- Manufacturer
- HILL-ROM, INC.
- Product Code
- HDD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN FOUND THAT THE HEX SCREW THAT SECURES THE CASTER TO THE BASE FRAME WAS MISSING. HE INSTALLED A NEW CASTER SCREW TO REPAIR THE BED.
Description of Event or Problem · 1
INFORMATION RECEIVED INDICATES WHEN THE BRAKES WERE SET THE BRAKE/STEER CASTER WOULD STILL SWIVEL.
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 |