BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CTLM SYSTEM MODEL 1020

    MDR report key: 1834512 · Received September 10, 2010

    Report

    Report Number
    3001452873-2010-00001
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    August 14, 2010
    Report Date
    September 7, 2010
    Manufacturer
    IMAGING DIAGNOSTIC SYSTEMS, INC.
    Product Code
    IZH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM WAS CONFIRMED TO BE RUNNING IN THE "IDLE" STATE DURING THE EVENT. THE SYSTEM HAD BEEN INSTALLED AND OPERATIONAL SINCE 06/11/2010. PRIOR TO BEING INSTALLED AT THE CURRENT LOCATION, THE SYSTEM HAD BEEN INSTALLED AND REMOVED FROM TWO OTHER SITES IN (B)(4) ON 07/15/2009 AND 11/01/2009. PER OUR SITE PLANNING GUIDE (B)(4), THE SYSTEM IS TO BE CONNECTED TO A 220VAC LINE. VOLTAGE READINGS WERE TAKEN ON TWO SEPARATE OCCASIONS AND FOUND TO BE 230VAC, 50HZ. THE SYSTEM HAS BEEN VALIDATED TO RUN BETWEEN 198VAC AND 250VAC, THEREFORE, THE SUPPLIED VOLTAGE IS WELL WITHIN RANGE. AFTER REPAIR, CURRENT READINGS WERE TAKEN AT FULL SYSTEM OPERATION AND FOUND TO BE BELOW 6 AMPS. THE CTLM MODEL 1020 WAS SAFETY TESTED TO IEC60601-1 IN 2000 AND AGAIN IN 2006. BOTH TESTS PASSED AND THE UL MARK HAS BEEN APPLIED SINCE 2000. THE POWER CORD IS UL LISTED AND CE MARKED FOR 250VAC AT 10AMPS. THIS CORD HAS BEEN IN USE ON (B)(4) SINCE JUNE, 2003 WITH NO OTHER INSTANCES OF OVERHEATING. ACTION WILL BE TAKEN TO VERIFY PROPER INSTALLATION ON ALL OTHER SYSTEMS USING THIS CORD. SYSTEMS FOUND WITH IMPROPERLY INSTALLED POWER CORDS WILL HAVE THE CORDS REPLACED. IN ADDITION, SERVICE PERSONNEL ARE BEING RETRAINED IN THE IMPORTANCE OF RETAINING FAILED COMPONENTS SHOULD IDSI'S SAFETY COMMITTEE REQUIRE THOSE COMPONENTS BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    (B)(4) IDSI'S CERTIFIED SERVICE ENGINEER FOR (B)(4), REPORTED THAT THE CTLM SYSTEM AC POWER CABLE HAD CAUGHT ON FIRE OVER THE WEEKEND OF (B)(6) 2010. THE CENTER WAS CLOSED AT THE TIME. THE POWER CORD SELF-EXTINGUISHED WITH NOTICEABLE SMOKE DAMAGE TO THE REAR CONSOLE COVER ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CTLM SYSTEM MODEL 1020 COMPUTED TOMOGRAPHY LASER MAMMOGRAPHY IZH IMAGING DIAGNOSTIC SYSTEMS, INC. 1020 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA