BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART FR3 ECG, BASIC BUNDLE, USENG

    MDR report key: 3871233 · Received April 16, 2014

    Report

    Report Number
    3030677-2014-01071
    Event Type
    Malfunction
    Date Received
    April 16, 2014
    Report Date
    April 9, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K111693
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT EVALUATION PENDING. ISSUE IS BEING REPORTED AS THE ISSUE WAS DISCOVERED DURING DEPLOYMENT.

    Description of Event or Problem · 1

    DURING DEPLOYMENT, THE USER IS QUESTIONING THE DEVICE'S ABILITY TO ANALYZE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233784 HEARTSTART FR3 ECG, BASIC BUNDLE, USENG MKJ MKJ PHILIPS MEDICAL SYSTEMS 861389

    Patients

    Seq Age Sex Outcome Treatment
    1