BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VINGMED

    MDR report key: 38684 · Received September 10, 1996

    Report

    Report Number
    38684
    Event Type
    Malfunction
    Date Received
    September 10, 1996
    Date of Event
    September 6, 1996
    Report Date
    September 9, 1996
    Manufacturer
    DIASONICS
    Product Code
    DXK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    EKG TECH WAS PERFORMING ECHOCARDIOGRAM OF PT WITH PREVIOUSLY IMPLANTED PACEMAKER. WHEN PART OF MACHINE TOUCHED PT'S BED, AN ARTIFACT RESEMBLING A PACEMAKER MALFUNCTION WAS REPRODUCED ON EKG STRIP. EKG PERFORMED ON PT AFTER TEST WAS IDENTICAL TO PRETEST EKG. CARDIOLOGIST FELT ABNORMAL EKG RESULT OF MALFUNCTION OF MACHINE AND WAS ARTIFACT ONLY. ECHOCARDIOGRAM MACHINE PART FELT TO BE CONTRIBUTING TO EVENT WAS REPLACED BY FACTORY SVC REP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VINGMED ECHOCARDIOGRAM MACHINE DXK DIASONICS CFM 750 *

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Other MEDTRONIC PACEMAKER MODEL 8340, SN UQ2207613H