BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX AIRWORTHY

    MDR report key: 3770469 · Received March 5, 2014

    Report

    Report Number
    1218950-2014-01200
    Event Type
    Malfunction
    Date Received
    March 5, 2014
    Report Date
    February 12, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 STATES THAT DURING INITIAL INSPECTION THE DEVICE DID NOT SHOCK IN THE 15 JOULE RANGE. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133338 HEARTSTART MRX AIRWORTHY DRO, LDD, MKJ MKJ PHILIPS MEDICAL SYSTEMS 861464

    Patients

    Seq Age Sex Outcome Treatment
    1