BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX-EMS DEFIBRILLATOR

    MDR report key: 1843827 · Received September 10, 2010

    Report

    Report Number
    1218950-2010-01561
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Report Date
    August 12, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED HAVING EXTERNAL POWER ISSUES WITH THIS UNIT. A PHILIPS FIELD SERVICE ENGINEER WENT TO THE CUSTOMER SITE TO EVALUATE THE UNIT. HE PERFORMED EXTENSIVE TESTING ON THE UNIT AND THE REPORTED ISSUE COULD NOT BE RECREATED. WE WILL CONSIDER THIS ISSUE A FAILURE. WE COULD NOT DETERMINE THE CAUSE AS THE FAILURE COULD NOT BE RECREATED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HAVING EXTERNAL POWER ISSUES WITH THIS UNIT.

    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