FDA Adverse Event
Malfunction
Summary report: N
AFFINITY BED
MDR report key: 1052840
·
Received May 27, 2008
Report
- Report Number
- 1824206-2008-02580
- Event Type
- Malfunction
- Date Received
- May 27, 2008
- Date of Event
- April 30, 2008
- Report Date
- April 30, 2008
- Manufacturer
- HILL-ROM RITTER
- Product Code
- HDD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE FACILITY PERFORMED THE REPAIR ON THE BED AND FOUND THE CAM PIVOT WAS BROKEN, WHICH DID NOT ALLOW THE BRAKE PEDAL TO SET.
Description of Event or Problem · 1
ALLEGED THE BRAKES WOULD NOT HOLD THE BED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AFFINITY BED | BIRTHING BED | HDD | HILL-ROM RITTER | 3600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |