BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX-EMS DEFIBRILLATOR

    MDR report key: 1925028 · Received November 22, 2010

    Report

    Report Number
    1218950-2010-02332
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Report Date
    October 26, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THE DEVICE FAILED THE DEFIB PORTION OF THE USER INITIATED OPERATIONAL CHECK. THERE WAS NO PATIENT INVOLVEMENT. THE UNIT WAS EVALUATED BY THE PHILIPS. THE SYMPTOM COULD NOT BE DUPLICATED AND THE DEVICE PASSED ALL TESTING, THEREFORE, WE CANNOT DETERMINE THE CAUSE. BASED ON THE CUSTOMER'S REPORT, WE ARE CONSIDERING THIS A MALFUNCTION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DEVICE FAILED THE DEFIB PORTION OF THE USER INITIATED OPERATIONAL CHECK. THERE WAS NO PATIENT INVOLVEMENT.

    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