BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 3063204 · Received February 27, 2013

    Report

    Report Number
    1218950-2013-00685
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Report Date
    February 2, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THE SCREEN IS BLACK AND MAKES NOISES IN THE BACKGROUND. THERE WAS NO REPORTED PT INVOLVEMENT. A PHILIPS REPAIR TECHNICIAN EVALUATED THE DEVICE AND CONFIRMED THE PROBLEM. THE FAULT WAS TRACED TO A FAULTY POWER PCA. REPLACING THE POWER PCA RESOLVED THE PROBLEM. ALL PERFORMANCE ASSURANCE TESTS PASSED. THE DEVICE WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SCREEN IS BLACK AND MAKES NOISES IN THE BACKGROUND. THERE WAS NO REPORTED PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85292 HEARTSTART MRX -EMS DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1