BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX - EMS DXEFIBRILLATOR

    MDR report key: 4003190 · Received June 26, 2014

    Report

    Report Number
    1218950-2014-03655
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Report Date
    June 4, 2014
    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

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS HEALTHCARE THAT THE HEARTSTART MRX DEFIBRILLATOR FAILED OPCHECK AND CALIBRATION FOR ETCO2. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373230 HEARTSTART MRX - EMS DXEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1