FDA Adverse Event
Malfunction
Summary report: N
AFFINITY 3
MDR report key: 1021509
·
Received March 26, 2008
Report
- Report Number
- 1824206-2008-00066
- Event Type
- Malfunction
- Date Received
- March 26, 2008
- Date of Event
- November 27, 2007
- Report Date
- November 27, 2007
- Manufacturer
- HILL-ROM RITTER
- Product Code
- HDD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EI
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE HILL-ROM TECHNICIAN ADJUSTED THE BRAKE/STEER CASTER TO REPAIR THE BED. THE AFFINITY SERVICE MANUAL (MAN 272) DOCUMENTS A FUNCTION CHECK FOR THE CASTER TIRES AND CENTRAL BRAKE AND STEER AS PART OF PREVENTATIVE MAINTENANCE. THE COMPONENTS SHOULD BE CHECKED FOR CUTS, WEAR, TREAD LIFE, ETC. AND THE BRAKES SHOULD BE CHECKED TO ENSURE THE BED WILL NOT MOVE WHEN THE BRAKE IS ACTIVATED. IF THE BED MOVES, INSPECTION FOR WEAR AND ADJUSTMENT MAY BE NECESSARY. THE STEERING PEDAL SHOULD ALSO BE CHECKED FOR PROPER LOCKING WHEN ACTIVATED.
Description of Event or Problem · 1
THE ACCOUNT ALLEGED THE BRAKES WERE FAULTY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AFFINITY 3 | BIRTHING BED | HDD | HILL-ROM RITTER | 3700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |