BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART FR3 ECG, BASIC BUNDLE, JAPAN

    MDR report key: 4349457 · Received December 11, 2014

    Report

    Report Number
    3030677-2014-02898
    Event Type
    Malfunction
    Date Received
    December 11, 2014
    Report Date
    November 26, 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). DEVICE INTERNAL MEMORY WAS REVIEWED. 510(K): K111693. CONCLUSION: HERE WAS NO FAULT FOUND WITH THIS DEVICE. A HEART MASSAGER WAS IN PLACE ON THE TIME OF THE EVENT INTERRUPTING THE ANALYSIS FROM THE DEVICE, WHICH IS ADVISED AGAINST IN THE INSTRUCTIONS FOR USE. AUDIO INSTRUCTIONS AND LABELING ARE PRESENT TO ASSIST THE USER IN OVERCOMING THE ARTIFACT. THE DEVICE PERFORMED ACCORDING TO SPECIFICATIONS.

    Description of Event or Problem · 1

    THE USER REPORTED THE PRESENCE OF NOISE DURING ECG ANALYZATION. PATIENT OUTCOME IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803644 HEARTSTART FR3 ECG, BASIC BUNDLE, JAPAN MKJ PHILIPS MEDICAL SYSTEMS 861389

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR