BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSHIBA

    MDR report key: 1386613 · Received March 18, 2009

    Report

    Report Number
    2020563-2009-00003
    Event Type
    Malfunction
    Date Received
    March 18, 2009
    Date of Event
    February 16, 2009
    Report Date
    March 2, 2009
    Manufacturer
    TOSHIBA MEDICAL SYSTEMS CORP
    Product Code
    JAK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER IS INVESTIGATING THE FAILED SRU. ADDITIONAL INFORMATION WILL BE SUPPLIED IF RELEVANT. CONCLUSIONS: THE SRU-H MODULE (HIGH VOLTAGE GENERATOR) WAS FOUND TO BE DEFECTIVE. IT WAS FOUND THAT THE SRU-H MODULE WAS DEFECTIVE. A REPLACEMENT WAS INSTALLED AND UNIT WAS WORKING NORMALLY. THE NEW UNIT WAS TURNED OVER FOR USE AND OBSERVED CASES. THE SYSTEM IS NOW UP AND RUNNING WITH NO PROBLEM.

    Description of Event or Problem · 1

    TOSHIBA RECEIVED A REPORT FROM A UNIVERSITY MEDICAL CENTER (B) (6) THAT AN INTERVENTIONAL RADIOLOGIST AND RADIOLOGY TECHNICIAN WERE PERFORMING A BIOPSY WHEN THEY NOTICED AN ELECTRICAL SMELL. ONE OR TWO MINUTES LATER, THEY HEARD A POPPING NOISE FROM BEHIND THE GANTRY AND SMOKE ROSE TO THE CEILING. THE SCANNER WAS TURNED OFF IMMEDIATELY AND THE PATIENT WAS REMOVED FROM THE AREA. THE PATIENT WAS NOT HARMED. THE FIRE COMPANY AND BIOMEDICAL ENGINEERING WERE CALLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOSHIBA SYSTEM X-RAY COMPUTED TOMOGRAPHY JAK TOSHIBA MEDICAL SYSTEMS CORP TSX-101A/6D

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR