BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGILENT TECHNOLOGIES -LAERDAL- FR2

    MDR report key: 1253490 · Received November 30, 2008

    Report

    Report Number
    MW5009124
    Event Type
    Injury
    Date Received
    November 30, 2008
    Date of Event
    November 30, 2008
    Report Date
    November 30, 2008
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SPEAKER FAILURE WHICH PREVENTS VOICE PROMPTS AND WARNINGS FROM BEING HEARD BY THE USER. THIS IS THE TENTH UNIT OWNED BY THIS AUTHORITY WHICH HAS SUFFERED FROM SPEAKER FAILURE IN THE LAST THREE YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AGILENT TECHNOLOGIES -LAERDAL- FR2 LAERDAL HEARTSTART FR2 MKJ FR2

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening