BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX-EMS DEFIBRILLATOR

    MDR report key: 1924935 · Received December 10, 2010

    Report

    Report Number
    1218950-2010-02567
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Report Date
    November 19, 2010
    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 FAILURE TO ACQUIRE 12-LEAD ECG SIGNAL LOSS. THERE WAS NO REPORT OF ADVERSE PT IMPACT. THE UNIT WAS EVALUATED BY 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 FAILURE TO ACQUIRE 12-LEAD ECG SIGNAL LOSS. THERE WAS NO REPORT OF 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