BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 1905611 · Received November 11, 2010

    Report

    Report Number
    1218950-2010-02252
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Report Date
    October 14, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT UNIT FAILED TO POWER UP. THE UNIT WAS EVALUATED LOCALLY AND THE FAILURE WAS CONFIRMED. REPLACEMENT OF THE POWER SUPPLY RESOLVED THE FAILURE. THE UNIT PASSED ALL POST SERVICE TESTING AND REMAINS AT 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 HEART START XL MKJ PHILIPS HEALTHCARE M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1