BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX-EMS DEFIBRILLATOR

    MDR report key: 1913480 · Received November 24, 2010

    Report

    Report Number
    1218950-2010-02376
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Report Date
    October 29, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT DURING TRANSPORT IN THE AMBULANCE THEY WERE UNABLE TO ACQUIRE 12-LEAD ECG. THE ISSUE SELF RESOLVED DURING TRANSPORT. THERE WAS NO REPORT OF PT IMPACT. THE UNIT WAS EVALUATED BY THE PHILIPS FIELD SERVICE ENGINEER (FSE). 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 THAT DURING TRANSPORT IN THE AMBULANCE, THEY WERE UNABLE TO ACQUIRE 12-LEAD ECG. THE ISSUE SELF RESOLVED DURING TRANSPORT. THERE WAS NO REPORT OF 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