BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPECTRA STO2

    MDR report key: 1170604 · Received September 16, 2008

    Report

    Report Number
    2184064-2008-00001
    Event Type
    Malfunction
    Date Received
    September 16, 2008
    Manufacturer
    HUTCHINSON TECHNOLOGY, INC.
    Product Code
    MUD
    PMA / PMN Number
    R061619
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE OVER TEMPERATURE ERROR MESSAGE FUNCTIONED AS INTENDED TO ALERT THE USER OF THE OVER TEMPERATURE CONDITION. CONCLUSIONS: A ROOT CAUSE INVESTIGATION WAS INITIATED ON (B) (6) 2008, FOR THE POWER LINE FILTER MALFUNCTION. THE 8051 PROCESSOR WITHIN THE DEVICE DETECTED THE HEAT FROM THE POWER LINE FILTER MALFUNCTION AND COMMUNICATED AN OVER TEMPERATURE ERROR MESSAGE, WHICH WAS DISPLAYED ON THE DEVICE SCREEN.

    Description of Event or Problem · 1

    A HEALTHCARE PROFESSIONAL OBSERVED A SYSTEM TEMPERATURE ERROR MESSAGE ON THE MONITOR SCREEN. MONITOR WAS IN THE ICU ATTACHED TO AN IV POLE AND PLUGGED INTO AN ELECTRICAL OUTLET DURING THE TIME THE OVER TEMPERATURE MESSAGE WAS OBSERVED. UPON EVALUATION OF THE RETURNED PRODUCT, OVERHEATING ISOLATED TO THE POWER LINE FILTER WAS OBSERVED. THE POWER LINE FILTER IS CONTAINED WITHIN AN ENCLOSURE WITH A UL FLAMMABILITY RATING OF 94V-0. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSPECTRA STO2 TISSUE OXYGENATION MONITOR MUD HUTCHINSON TECHNOLOGY, INC. 650

    Patients

    Seq Age Sex Outcome Treatment
    1