BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX - EMS DEFIB

    MDR report key: 3945257 · Received May 6, 2014

    Report

    Report Number
    1218950-2014-02544
    Event Type
    Malfunction
    Date Received
    May 6, 2014
    Report Date
    April 9, 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). A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS HEALTHCARE THAT DURING PREVENTATIVE MAINTENANCE, THE HEARTSTART MRX CHARGED THE DEFIB CIRCUIT UNEXPECTEDLY. THERE WAS NO REPORTED IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271004 HEARTSTART MRX - EMS DEFIB MKJ PHILIPS MEDICAL SYSTEMS M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1