BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISUALASE THERMAL THERAPY SYSTEM

    MDR report key: 3862194 · Received March 3, 2014

    Report

    Report Number
    3005726841-2014-00002
    Event Type
    Malfunction
    Date Received
    March 3, 2014
    Date of Event
    February 7, 2014
    Report Date
    February 7, 2014
    Manufacturer
    BIOTEX, INC.
    Product Code
    GEX
    PMA / PMN Number
    071328
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A FEW DAYS PRIOR TO THE PROCEDURE, (B)(6) HOSPITAL BIOMED PERSONNEL PERFORMED ROUTINE TESTING OF THE SYSTEM. AT THIS TIME, IT IS BELIEVED, THE MOTHERBOARD SUSTAINED DAMAGE THAT WAS NOT KNOWN AT THE TIME OF THE DRY RUN TEST THAT IS PERFORMED BEFORE EACH PROCEDURE. THE SYSTEM BOOTED UP AS EXPECTED BUT THE CONNECTION BETWEEN THE LASER AND THE CPU WAS NOT DETECTED AND A WARNING SCREEN DISPLAYED.

    Description of Event or Problem · 1

    DURING THE START OF A CRANIAL ABLATION, AT (B)(6) HOSPITAL, THE VISUALASE THERMAL THERAPY SYSTEM HAD A WARNING DISPLAY ON THE MONITOR THAT THERE WAS NOT CONNECTIVITY BETWEEN THE LASER AND THE COMPUTER. THE VISUALASE CLINICAL REPRESENTATIVE CONTACTED BIOTEX AND IT WAS DETERMINED THAT THERE WAS FAILURE WITH THE MOTHERBOARD. A BIOTEX REPRESENTATIVE REPLACED TH CPU WHILE THE PATIENT WAS UNDER ANESTHESIA. THE DELAY WAS APPROXIMATELY ONE HOUR OF THE 9 HOUR PROCEDURE. THE PROCEDURE WAS PERFORMED AND NO FURTHER INCIDENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128399 VISUALASE THERMAL THERAPY SYSTEM VTTS GEX BIOTEX, INC. VTT 100 100725-001

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK