BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 5233758 · Received November 18, 2015

    Report

    Report Number
    1218950-2015-06200
    Event Type
    Malfunction
    Date Received
    November 18, 2015
    Report Date
    October 26, 2015
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    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

    A FOLLOW UP REPORT WILL BE SUBMITTED AFTER THE DEVICE HAS BEEN RECEIVED BY PHILIPS FOR EVALUATION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT THERE ARE "UNBELIEVABLE" ETCO2 READINGS ON THE MRX DEVICE. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763376 HEARTSTART MRX -EMS DEFIBRILLATOR DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1