BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 1930507 · Received November 30, 2010

    Report

    Report Number
    1218950-2010-02420
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Report Date
    November 4, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT THE UNIT FAILED TO POWER UP ON AC POWER AND THE CHARGE LED WAS NOT LIT. THE UNIT WAS EVALUATED LOCALLY BY A PHILIPS FIELD SERVICE ENGINEER (FSE), AND THE FAILURE WAS VERIFIED. THE FSE STATED THAT THIS FAILURE WAS POSSIBLY DUE TO A POWER SURGE AT THE FACILITY. REPLACING 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 ON AC POWER AND THE CHARGE LED WAS NOT LIT.

    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