BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY IV BED

    MDR report key: 2904352 · Received November 28, 2012

    Report

    Report Number
    1824206-2012-07760
    Event Type
    Malfunction
    Date Received
    November 28, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 7, 2012
    Manufacturer
    HILL-ROM, INC.
    Product Code
    HDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACCOUNT REPLACED THE BRAKE DETENT TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    THE ACCOUNT ALLEGED THAT THE WHEN THE BRAKES ARE ENGAGED THE BRAKES WOULD NOT HOLD. NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AFFINITY IV BED BIRTHING BED HDD HILL-ROM, INC. 3700

    Patients

    Seq Age Sex Outcome Treatment
    1