BEUDAMED
    FDA Adverse Event Summary report: N

    TREADMILL

    MDR report key: 21638 · Received May 3, 1995

    Report

    Report Number
    MW1005801
    Date Received
    May 3, 1995
    Date of Event
    March 29, 1995
    Report Date
    April 5, 1995
    Manufacturer
    MARQUETTE MEDICA,INC.
    Product Code
    IOL
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT IS A 45-YR-OLD SLIGHTLY OBESE FEMALE WHO WAS REFERRED TO RPTR FOR EVALUATION OF ATYPICAL CHEST PAIN. RPTR SCHEDULED THE PT FOR A STRESS TEST. RPTR ASKED THE PT TO STAND ON THE TREADMILL MACHINE AND PRESSED THE TREADMILL "START" BUTTON. THE BELT GRADUALLY BEGAN TO MOVE AND THE PT BEGAN TO WALK. AT THIS POINT, RPTR PRESSES THE EXERCISE BUTTON AND THE TREADMILL WENT INTO THE FIRST STAGE OF BRUCE. HOWEVER, THE SPEED CONTINUED TO GO FASTER AND FASTER. THE PT BEGAN TO RUN, BUT COULD NOT KEEP UP WITH THE MACHINE. RPTR'S ATTEMPTS TO SHUT OFF THE TREADMILL BY PRESSING THE TREADMILL "STOP" BUTTON WERE UNSUCCESSFUL. FINALLY, THE PT FELL AND RPTR LIFTED HER OFF THE BELT. DURING THIS PROCESS, SHE DEVELOPED ABRASIONS ON BOTH HER KNEES. SHE HAD NO OTHER OBVIOUS SIGNS OF INJURY. RPTR APPLIED AN OINTMENT AND BANDAGED BOTH THE KNEES. SHE WAS ABLE TO WALK WITHOUT ANY DIFFICULTY. NO OTHER BONE INJURIES OR SOFT TISSUE INJURIES WERE EVIDENT. THE PT WAS MONITORED FOR ANOTHER 20-30 MINUTES, AND SHE WAS COMFORTABLE GOING HOME. SHE WAS A LITTLE BIT SHAKEN UP BUT WAS NOT UPSET. THE TREADMILL FINALLY STOPPED WHEN RPTR KEPT PUSHING THE TREADMILL "STOP" BUTTON. TREADMILL WAS RESTARTED AGAIN, AND THIS TIME THE MOMENT THE TREADMILL "START" BUTTON WAS PRESSED, INSTEAD OF THE BELT STARTING SLOWLY, IT STARTED AT A VERY RAPID PACE. ALSO, IT WOULD NOT TAKE ANY COMMAND FROM THE CONSOLE TO INCREASE OR DECREASE THE SPEED OR ANYTHING ELSE. AGAIN, IT WOULD NOT TAKE ANY COMMAND FROM THE CONSOLE TO INCREASE OR DECREASE THE SPEED OR ANYTHING ELSE. AGAIN, THE TREADMILL "STOP" BUTTON WILL NOT TAKE THE COMMAND UNTIL IT IS PRESSED FOR ABOUT 5 OR MORE SECONDS BEFORE IT WILL SHUT OFF THE TREADMILL MACHINE. RPTR STATES THERE IS NO EMERGENCY STOP BUTTON. RPTR IMMEDIATELY CONTACTED MFR REPRESENTATIVE WHO CAME TO CHECK THE MACHINE ON 3/31/95. REP TOLD RPTR THAT THE MACHINE IS STUCK IN A HIGHER GEAR AND WILL NOT RESPOND TO ANY OF THE COMMANDS. MFR WILL ALSO BE SENDING RPTR THE NECESSARY FORMS TO FILL SINCE THE PT WAS INJURED IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TREADMILL TREADMILL IOL MARQUETTE MEDICA,INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR