BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX-EMS DEFIBRILLATOR

    MDR report key: 3761126 · Received December 31, 2013

    Report

    Report Number
    1218950-2013-06846
    Event Type
    Malfunction
    Date Received
    December 31, 2013
    Report Date
    December 9, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    UNKNOWN

    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 HAVING ISSUES WITH THE ETCO2 FUNCTIONALITY ON THEIR DEFIBRILLATOR. PHILLIPS PROVIDED TECHNICAL SUPPORT TO ASSIST THE CUSTOMER WITH TROUBLESHOOTING THE PROBLEM. THE CUSTOMER HAS REQUESTED REPAIR OF THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682532 HEARTSTART MRX-EMS DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1