BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART FR3 ECG, BASIC BUNDLE, JAPAN

    MDR report key: 3874743 · Received April 25, 2014

    Report

    Report Number
    3030677-2014-01135
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Report Date
    April 18, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PENDING DEVICE INVESTIGATION OF THE PATIENT USE EVENT. 510(K): K111693.

    Description of Event or Problem · 1

    DURING DEPLOYMENT, THE USER IS QUESTIONING THE "NO SHOCK" NOTIFICATION GIVEN BY THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250639 HEARTSTART FR3 ECG, BASIC BUNDLE, JAPAN MKJ PHILIPS MEDICAL SYSTEMS 861389

    Patients

    Seq Age Sex Outcome Treatment
    1