BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX - EMS DEFIBRILLATOR

    MDR report key: 2041434 · Received March 9, 2011

    Report

    Report Number
    1218950-2011-00603
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Report Date
    February 7, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT SOMETIMES THE DEVICE POWER CYCLES WHEN TURNED ON AND PT EVENT DATA IS WIPED OUT. THERE WAS NO REPORTED ADVERSE PT IMPACT. PHILIPS EVALUATED THE DEVICE AND CONFIRMED THE FAILURE. THE PROBLEM WAS RESOLVED BY REPLACEMENT OF THE INTERNAL DATA CARD. THE DEVICE PASSED ALL PERFORMANCE VERIFICATION TESTS AND WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SOMETIMES THE DEVICE POWER CYCLES WHEN TURNED ON AND PT EVENT DATA IS WIPED OUT. THERE WAS NO REPORTED ADVERSE 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