BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART FR3

    MDR report key: 3800521 · Received February 11, 2014

    Report

    Report Number
    3030677-2014-00503
    Event Type
    Malfunction
    Date Received
    February 11, 2014
    Report Date
    January 24, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K111693
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PENDING EVAL OF THE PT USE EVENT.

    Description of Event or Problem · 1

    DURING A DEPLOYMENT WHERE THE PT WAS SUCCESSFULLY RESUSCITATED, THE USER QUESTIONED THE DEVICES "NO SHOCK ADVISED" DECISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89011 HEARTSTART FR3 MKJ PHILIPS MEDICAL SYSTEMS 861389

    Patients

    Seq Age Sex Outcome Treatment
    1