BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODEMASTER XL+

    MDR report key: 1740932 · Received June 25, 2010

    Report

    Report Number
    1218950-2010-01004
    Event Type
    Malfunction
    Date Received
    June 25, 2010
    Report Date
    October 21, 2009
    Manufacturer
    AGILENT TECHNOLOGIES, INC.
    Product Code
    LDD
    PMA / PMN Number
    K954957
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THE DEVICE FAILED TO POWER UP. THIS DEFIBRILLATOR IS OVER 11 YEARS OLD AND THIS MODEL HAS BEEN OUT OF PHILIPS SUPPORT SINCE DECEMBER 2006. THE DEVICE WAS EVALUATED LOCALLY. MULTIPLE PARTS WERE REPLACED THE RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DEVICE FAILED TO POWER UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CODEMASTER XL+ LDD, MKJ, DQA LDD AGILENT TECHNOLOGIES, INC. M1722B

    Patients

    Seq Age Sex Outcome Treatment
    1