BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY BIRTHING BED

    MDR report key: 3222048 · Received July 5, 2013

    Report

    Report Number
    1824206-2013-03357
    Event Type
    Malfunction
    Date Received
    July 5, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 10, 2013
    Manufacturer
    HILL-ROM, INC.
    Product Code
    HDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACCOUNT REPLACED THE BRAKE CASTER TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    THE ACCOUNT ALLEGED THE BRAKES ARE RATCHETING WHILE IN BRAKE MODE. NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307615 AFFINITY BIRTHING BED BIRTHING BED HDD HILL-ROM, INC. 3600

    Patients

    Seq Age Sex Outcome Treatment
    1