BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 3191158 · Received June 14, 2013

    Report

    Report Number
    1218950-2013-02377
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Report Date
    May 22, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY WERE UNABLE TO ACQUIRE PADS/PADDLES ECG DURING A PT EVENT IN AN AMBULANCE. THE USERS SWITCHED TO A DIFFERENT DEFIBRILLATOR TO TREAT THE PT. THERE WAS NO PT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272146 HEARTSTART MRX MKJ PHILIPS MEDICAL SYSTEMS M3535A

    Patients

    Seq Age Sex Outcome Treatment
    1