BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 2051879 · Received March 14, 2011

    Report

    Report Number
    1218950-2011-00683
    Event Type
    Malfunction
    Date Received
    March 14, 2011
    Report Date
    February 14, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT THE UNIT FAILED TO POWER UP. THERE WAS NO REPORT OF PT INVOLVEMENT. THE UNIT WAS EVALUATED AT PHILIPS AND THE FAILURE WAS FURTHER IDENTIFIED AS FAILED DISPLAY AND FAILURE TO TURN OFF. BOTH THE PROCESSOR PCA AND THE DISPLAY WERE REPLACED FOR THIS FAILURE. DUE TO MULTIPLE PARTS BEING REPLACED, WE CANNOT DETERMINE THE CAUSE OF THIS REPORTED FAILURE. THE UNIT PASSED ALL POST SERVICING TESTING AND WAS SHIPPED BACK 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 -EMS DEFIBRILLATOR MKJ PHILIPS HEALTHCARE M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1