BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUINTON Q55 SERIES 90 TREADMILL

    MDR report key: 1021933 · Received March 28, 2008

    Report

    Report Number
    3014398-2008-00008
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    March 26, 2008
    Report Date
    March 28, 2008
    Manufacturer
    CARDIAC SCIENCE CORPORATION
    Product Code
    IOL
    PMA / PMN Number
    K820478
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER WAS DISPATCHED TO SITE. THE INVESTIGATION FOUND ONE BROKEN AND ONE MISSING STANDOFF SCREW ON THE TREADMILL CONTROL CONNECTOR IN THE POWER PANEL ON THE SIDE OF THE TREADMILL. AS A RESULT OF THE LOOSE AND MISSING STANDOFF SCREWS, THE CONNECTOR WAS ABLE TO PULL OUT ABOUT 3/8" AND CONTACT A METAL PLATE CAUSING THE DRIVE MOTOR TO START UNEXPECTEDLY. THE FIELD SERVICE ENGINEER REPLACED THE MISSING STANDOFF AND HOLDING SCREW AND RETIGHTENED THE LOOSE ONE. HE VERIFIED PROPER OPERATION AND PERFORMED A TREADMILL CALIBRATION. ACCORDING TO OUR RECORDS GOING BACK TO NOVEMBER 2003, THIS TREADMILL HAS NOT BEEN SERVICED OR MAINTAINED BY AUTHORIZED CARDIAC SCIENCE SERVICE PERSONNEL.

    Description of Event or Problem · 1

    BIOMED CALLED AND STATED THE TECHNICIAN WAS SITTING ON A STOOL WHICH WAS PLACED ON THE WALKING BELT OF THE TREADMILL WHILE PERFORMING A DRUG STUDY ON A PATIENT WHO WAS LYING ON A NEARBY BED. HE REPORTED THE TREADMILL STARTED ON ITS OWN. THE TECHNICIAN WAS THROWN OFF THE TREADMILL AND WENT TO PATIENT SERVICES TO BE CHECKED OUT; THE NEXT DAY, SHE REPORTED SHE WAS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUINTON Q55 SERIES 90 TREADMILL CARDIAC STRESS TESTING TREADMILL IOL CARDIAC SCIENCE CORPORATION 000346-001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1