BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 1930510 · Received November 30, 2010

    Report

    Report Number
    1218950-2010-02415
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Report Date
    November 1, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT THE UNIT FAILED TO POWER UP. THE UNIT WAS EVALUATED AT PHILIPS, AND THE FAILURE WAS CONFIRMED. MULTIPLE PARTS WERE REPLACED TO RESOLVE THE ISSUE, AND AS A RESULT, WE ARE UNABLE TO DETERMINE THE EXACT CAUSE OF THE FAILURE. THE UNIT PASSED ALL POST-SERVICE TESTING AND WAS RETURNED TO THE CUSTOMER SITE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT FAILED TO POWER UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART MRX MKJ PHILIPS HEALTHCARE M3535A

    Patients

    Seq Age Sex Outcome Treatment
    1