BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY BED

    MDR report key: 2063100 · Received March 16, 2011

    Report

    Report Number
    1824206-2011-01624
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    May 9, 2008
    Report Date
    May 9, 2008
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN FOUND THAT THE LEFT CAM PIVOT WAS CRANKED CAUSING THE LEFT FOOT BRAKE CASTER NOT TO ENGAGE IN THE BRAKE MODE. THE TECHNICIAN REPLACED THE CAM PIVOT AND ADJUSTED THE BRAKE CASTER TO RESOLVE THE ISSUE. THIS MDR IS A RESULT OF CAPA ACTIVITY FOR THE RETROSPECTIVE REVIEW OF COMPLAINTS.

    Description of Event or Problem · 1

    THE TECHNICIAN ALLEGED THAT THE LEFT FOOT BRAKE CASTER DID NOT HOLD WHEN THE BRAKES WERE ENGAGED. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AFFINITY BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 3700

    Patients

    Seq Age Sex Outcome Treatment
    1