BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BURDICK T600 TREADMILL

    MDR report key: 1873609 · Received September 14, 2010

    Report

    Report Number
    3014398-2010-00029
    Event Type
    Malfunction
    Date Received
    September 14, 2010
    Date of Event
    August 16, 2010
    Report Date
    August 16, 2010
    Manufacturer
    CARDIAC SCIENCE CORPORATION
    Product Code
    IOL
    PMA / PMN Number
    K910867
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CARDIAC SCIENCE FIELD SERVICE ENGINEER WAS DISPATCHED TO THE SITE. HE REPLACED A TREADMILL CONTROL BOARD AND INTERFACE CABLE. THE SYSTEM WAS TESTED TWICE IN A BRUCE PROTOCOL WITH NO PROBLEMS FOUND. A FUNCTIONAL TEST WAS ALSO COMPLETED. THE ORIGINAL PARTS ARE BEING RETURNED TO THE MANUFACTURER. WHEN FURTHER INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    CUSTOMER STATED THEY HAD JUST STARTED THE TREADMILL AT MINIMUM SPEED. THE PATIENT STEPPED ON THE TREADMILL AND A SHORT TIME LATER THE TREADMILL SPED UP TO MAXIMUM SPEED. AT SOME POINT THE PATIENT FELL OFF THE TREADMILL. PATIENT REPORTED SOME MINOR SORENESS. THE DOCTORS CHECKED HER OVER SEVERAL TIMES AND SAID SHE WAS OKAY. PATIENT REFUSED ANY FURTHER TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BURDICK T600 TREADMILL CARDIAC STRESS TESTING TREADMILL IOL CARDIAC SCIENCE CORPORATION 92401 NA

    Patients

    Seq Age Sex Outcome Treatment
    1