BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENERAL ELECTRIC TREADMILL

    MDR report key: 678237 · Received January 23, 2006

    Report

    Report Number
    MW1037854
    Event Type
    Malfunction
    Date Received
    January 23, 2006
    Date of Event
    January 17, 2006
    Report Date
    January 23, 2006
    Manufacturer
    G.E. MEDICAL SYSTEMS
    Product Code
    IOL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    TREADMILL STOPPED DURING CASE STUDY, TECH SUPPORT RECOMMENDED TO PERFORM SELF CALIBRATION ON UNIT. DISCONNECTED STOP SWITCH AND CONTROL CABLE FROM STRESS EKG MACHINE. PERFORMED SELF CALIBRATION ON UNIT AS RECOMMENDED BY TECH SUPPORT. CONNECTED CABLING BACK TO TREADMILL, CONNECTED PT SIMULATOR TO STRESS EKG AND UNIT, SIMULATED TEST AND TREADMILL WORKED PROPERLY. ALL STAGES VIA THE SYSTEM THE BELT INCREASED IN SPEED AND ELEVATION THEN SELECTED TO DO SO. NO HESITATION NOTICED OR TREADMILL STOPPING, UNLESS COMMANDED TO DO SO OR STOP SWITCH PRESSED. RAN BRUCE PROTOCOL VIA A MANUAL CHECK ADVANCING THRU STAGES MANUALLY, RAN THRU TEST AGAIN, BRUCE PROTOCOL, AND ALLOWED STAGES TO COMPLETE AND ADVANCE AS PROGRAMMED. TREADMILL WORKED CORRECTLY. EKG TECH SAID UNIT STOPED IN BRUCE PROTOCOL PROGRAM, APPROXIMATELY 2 MINUTES INTO FIRST STAGE. SHE COMPLETED TEST BY MANUALLY SELECTING THE SPEED AND ANGLE SETTINGS DURING THE STRESS TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENERAL ELECTRIC TREADMILL TREADMILL IOL G.E. MEDICAL SYSTEMS T2000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *