BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX - EMS DEFIBRILLATOR

    MDR report key: 2051371 · Received April 4, 2011

    Report

    Report Number
    1218950-2011-00898
    Event Type
    Malfunction
    Date Received
    April 4, 2011
    Report Date
    March 7, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE SCREEN IS BLANK WHEN TURNED ON. THERE WAS NO REPORT OF PT IMPACT. THE UNIT WAS EVALUATED BY A PHILIPS FIELD SVC ENGINEER. THE DISPLAY ASSEMBLY AND PROCESSOR PCA WERE REPLACED TO ADDRESS THE PROBLEM SITUATION. THE DEVICE PASSED ALL PERFORMANCE AND ASSURANCE TESTS AND IF CERTIFIED TO BE USED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SCREEN IS BLANK WHEN TURNED ON. THERE WAS NO REPORT OF PT IMPACT.

    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