BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY BED

    MDR report key: 2033862 · Received March 23, 2011

    Report

    Report Number
    1824206-2011-01796
    Event Type
    Malfunction
    Date Received
    March 23, 2011
    Date of Event
    December 14, 2010
    Report Date
    December 14, 2010
    Manufacturer
    HILL-ROM, INC.
    Product Code
    HDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACCOUNT REPLACED THE CAM PIVOTS AND BUSHINGS TO RESOLVE THE ISSUE. THIS MDR IS A RESULT OF CAPA ACTIVITY FOR THE RETROSPECTIVE REVIEW OF COMPLAINTS.

    Description of Event or Problem · 1

    ACCOUNT ALLEGED THAT THE CAM PIVOTS ARE DAMAGED ON THE FOOT SUPPORT. NO PT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AFFINITY BED BIRTHING BED HDD HILL-ROM, INC. 405

    Patients

    Seq Age Sex Outcome Treatment
    1