BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX-EMS DEFIBRILLATOR

    MDR report key: 2961012 · Received January 15, 2013

    Report

    Report Number
    1218950-2013-00187
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Report Date
    December 27, 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 AN AUTHORIZED PHILIPS REP. THE SYMPTOM WAS NOT DUPLICATED. THE DEVICE PASSED ALL TESTING AND WAS RETURNED TO SVC. WE ARE CONSIDERING THIS A MALFUNCTION BASED ON THE CUSTOMER'S DESCRIPTION ONLY. WE ARE UNABLE TO DETERMINE THE CAUSE AS THE SYMPTOM WAS NOT REPRODUCED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FAILURE TO DISCHARGE USING EXTERNAL PADDLES. THERE WAS NO REPORTED PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21997 HEARTSTART MRX-EMS DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1