BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 3880824 · Received May 29, 2014

    Report

    Report Number
    1218950-2014-03007
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Report Date
    May 8, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 TO PHILIPS HEALTHCARE THAT THERE WAS AN "INTERRUPTION ANALYSIS BY DETECTING ARTIFACTS" WHILE USING THE HEARTSTART MRX. THERE WAS NO REPORT PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316872 HEARTSTART MRX -EMS DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3536J

    Patients

    Seq Age Sex Outcome Treatment
    1