BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 2910669 · Received December 4, 2012

    Report

    Report Number
    1218950-2012-03984
    Event Type
    Malfunction
    Date Received
    December 4, 2012
    Report Date
    November 9, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED A FAILURE TO ACQUIRE 12 LEAD ECG. THERE IS NO REPORT OF PT INVOLVEMENT. THE DEVICE WAS SENT TO THE PHILIPS BENCH FOR EVALUATION. THE REPORTED 12 LEAD ECG ISSUE COULD NOT BE REPRODUCED. THE DEVICE PASSED ALL TESTING AND WAS RETURNED TO THE CUSTOMER SITE. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE REPORTED ISSUE AS THE SYMPTOM COULD NOT BE REPRODUCED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FAILURE TO ACQUIRE 12 LEAD ECG. THERE IS NO REPORT OF 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