BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX - EMS DEFIBRILLATOR

    MDR report key: 3060708 · Received March 26, 2013

    Report

    Report Number
    1218950-2013-01043
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Report Date
    March 1, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED AN INTERMITTENT ISSUE FOR 12 LEAD ECG. THERE WAS NO NEGATIVE PT IMPACT. THE DEVICE WAS EVALUATED BY A PHILIPS FSE. THE REPORTED SYMPTOM COULD NOT BE REPRODUCED. THE DEVICE PASSED ALL REQUIRED TESTING. NO TROUBLE WAS FOUND. THE DEVICE REMAINS AT THE CUSTOMER SITE FOR USE. THE REPORTED SYMPTOM COULD NOT BE REPRODUCED AND WE ARE THEREFORE UNABLE TO DETERMINE THE CAUSE OF THE REPORTED SYMPTOM.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN INTERMITTENT ISSUE FOR 12 LEAD ECG. THERE WAS NO NEGATIVE PT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123067 HEARTSTART MRX - EMS DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1