BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX-EMS DEFIBRILLATOR

    MDR report key: 2851422 · Received October 30, 2012

    Report

    Report Number
    1218950-2012-03632
    Event Type
    Malfunction
    Date Received
    October 30, 2012
    Report Date
    October 3, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS EVALUATED BY A PHILIPS AUTHORIZED DISTRIBUTOR AND THE STATED PROBLEM WAS CONFIRMED. THE AC POWER CORD WAS FOUND TO HAVE BEEN THE CAUSE OF THIS ISSUE. REPLACING THE AC POWER CORD RESOLVED THE PROBLEM. THE DEVICE PASSED OPERATIONAL PERFORMANCE TESTING AND WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED POWER ISSUES CONSIDERED TO BE A FAILURE TO POWER UP WITH AC POWER ONLY. THERE WAS NO PT INVOLVEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1