BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARQUETTE ELECTRONICS INC.

    MDR report key: 105075 · Received June 30, 1997

    Report

    Report Number
    105075
    Event Type
    Injury
    Date Received
    June 30, 1997
    Date of Event
    March 25, 1997
    Report Date
    March 28, 1997
    Manufacturer
    MARQUETTE ELECTRONICS INC.
    Product Code
    IOL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A 77 YEAR OLD FEMALE UNDER GOING A STRESS TEST. PT. WALKED OVER TO TREADMILL & MACHINE SET ON MANUAL MODE. 1MPH 5% GRADE ENTERED, THEN 1.7 MPH 10% GRADE & THEN SUBSEQUENTLY 2.5 MPH 12% GRADE. UPON BEING SET AT THIS, THE MACHINE MADE A FUNNY NOISE & "TOOK OFF", INCREASING ITS SPEED & GRADE OF ITS OWN ACCORD. BUTTONS ON MACHINE FROZE UP & WOULDN'T WORK. IT ALSO WOULDN'T PRINT OUT AN EKG READING. PT. ON TREADMILL FEEL & HAD TO BE ADMITTED TO THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARQUETTE ELECTRONICS INC. MACI COMPUTER/TREADMILL IOL MARQUETTE ELECTRONICS INC. KIE91437F (COMPUTER) MODEL 1900

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization NA (COMPUTER RUNS TREADMILL)