BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EUREKA COLLIMATOR

    MDR report key: 1593429 · Received January 22, 2010

    Report

    Report Number
    1423380-2009-00031
    Event Type
    Malfunction
    Date Received
    January 22, 2010
    Date of Event
    December 29, 2009
    Report Date
    January 22, 2010
    Manufacturer
    MIDMARK CORPORATION
    Product Code
    IZW
    PMA / PMN Number
    K810598
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION OF THE UNIT REVEALED THAT THE TRIAC HAD FAILED. THE CERAMIC INSULATOR, WHICH IS USED TO REMOVE THE HEAT FROM THE TRIAC AND ELECTRICALLY ISOLATE THE UNIT FROM GROUND, WAS BROKEN, ISOLATING THE TRIAC FROM THE CHASSIS. THIS CAUSED THE TRIAC TO OVERHEAT AND FAIL IN A SHORTED MODE. THE TRIAC WAS REPLACED AND THE UNIT OPERATED NORMALLY. IN ADDITION, A COLLIMATOR (B) (4) WAS TESTED TO SIMULATE THE FAILURE MODE. THE CUSTOMER COMPLAINT ALLEGING "FIRE" ASSOCIATED WITH A SHORTED OUT LAMP CIRCUIT COULD NOT BE DUPLICATED.

    Description of Event or Problem · 1

    A DEALER SERVICE ENGINEER CALLED PROGENY ON (B) (6) 2009 REGARDING A COLLIMATOR, (B) (4), WHOSE LAMP CIRCUIT FAILED IN THE "ON" CONDITION CAUSING THE COVER TO BEGIN TO MELT. THE CUSTOMER ALLEGED THAT THE COLLIMATOR INTERNAL WIRING INSULATION CAUGHT FIRE AND CONTINUED TO BURN UNTIL THE WIRING CONNECTION FAILED WHICH STOPPED THE ELECTRIC CURRENT AND BURNING CEASED. NO INJURIES WERE REPORTED. THE UNIT WAS REPAIRED BY PROGENY TECHNICIAN ON 12/28/2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EUREKA COLLIMATOR IZW MIDMARK CORPORATION LINEAR II

    Patients

    Seq Age Sex Outcome Treatment
    1