BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGHTSPEED 16 SLICE

    MDR report key: 1647730 · Received March 26, 2010

    Report

    Report Number
    2126677-2010-00002
    Event Type
    Malfunction
    Date Received
    March 26, 2010
    Date of Event
    February 24, 2010
    Report Date
    February 24, 2010
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    JAK
    PMA / PMN Number
    K030420
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    GE'S INVESTIGATION INCORPORATED THE FOLLOWING ELEMENTS: ERROR LOG REVIEWS, CONTROL BOARD INSPECTION, SERVICE DOCUMENT REVIEW, AND ANALYSIS OF THE EVENT SCENARIO. INSPECTION OF THE RETURNED CONTROL BOARD AND REVIEW OF THE ERROR LOGS REVEALED A FAILED TRANSISTOR ON THE BOARD. THE TRANSISTOR WAS DETERMINED TO HAVE SHORTED AROUND THE TIME OF THE EVENT. THE REVIEWS ALSO REVEALED THAT THE ENGINEER TURNED ON THE "MANUAL ENABLE" SWITCH. BOTH THE FAILED TRANSISTOR AND ACTIVATED MANUAL ENABLE SWITCH WOULD CAUSE AN OVERHEAT. ACCORDING TO THE REPORT, THE FIRE OCCURRED DURING A PHANTOM CALIBRATION PROCEDURE, WHICH INDICATED THAT THE PDU WAS ENERGIZED AT THE TIME. ALSO, THE PDU COVER WAS NOT ATTACHED AT THIS TIME. THIS COVER IS COMPOSED OF FLAME RETARDANT MATERIAL THAT, IF ATTACHED IN CONJUNCTION WITH THE SYSTEM DESIGN, WOULD HAVE PREVENTED THE THERMAL EVENT. A REVIEW OF THE SERVICE DOCUMENTATIONS INSTRUCTS SERVICE PROVIDERS THAT THE PDU COVERS IS TO BE IN PLACE AND THE PDU DE-ENERGIZED PRIOR TO WORKING ON THE SYSTEM. BASED ON THE INVESTIGATION FINDINGS, THE PROBABLE ROOT CAUSE OF THE THERMAL EVENT WAS A RESULT OF A COMBINATION OF THE FOLLOWING FAILURES/ SCENARIOS: A SHORTED TRANSISTOR, MANUAL ENABLE SWITCH WAS TURNED ON, PDU WAS ENERGIZED DURING THE PHANTOM CALIBRATION, AND THE PDU FLAME RETARDANT COVER WAS NOT ATTACHED DURING THE CALIBRATION PROCEDURE.

    Description of Event or Problem · 1

    A THERMAL COMPONENT FAILURE WAS REPORTED TO HAVE OCCURRED ON THE CT SYSTEM'S POWER DISTRIBUTION UNIT (PDU) WHILE THE SYSTEM WAS BEING SERVICED BY A THIRD PARTY SERVICE ENGINEER. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONALLY, THERE WAS NO INJURY REPORTED. PRIOR TO THE EVENT, THE ENGINEER REMOVED THE PDU COVER AND TURNED ON THE "MANUAL ENABLE" SWITCH IN ORDER TO TROUBLESHOOT THE PDU COMPONENT. THEN THE ENGINEER PROCEEDED TO PERFORM A PHANTOM CALIBRATION PROCEDURE, DURING WHICH THE REPORTED THERMAL EVENT OCCURRED. THE ENGINEER IMMEDIATELY EXTINGUISHED THE FIRE SO THAT THE DAMAGE WAS ISOLATED TO THE PDU CONTROL BOARD AND PROTECTIVE SENSOR. THE PDU CONTROL BOARD WAS REPLACED. THE SYSTEM WAS VERIFIED TO BE PERFORMING ACCORDING TO SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGHTSPEED 16 SLICE JAK GE MEDICAL SYSTEMS, LLC 2378661-11

    Patients

    Seq Age Sex Outcome Treatment
    1