BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGENY JB-70

    MDR report key: 1545068 · Received November 10, 2009

    Report

    Report Number
    1423380-2009-00021
    Event Type
    Malfunction
    Date Received
    November 10, 2009
    Date of Event
    October 13, 2009
    Report Date
    November 4, 2009
    Manufacturer
    MIDMARK CORPORATION
    Product Code
    EHD
    PMA / PMN Number
    K020070
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A DESIGN CHANGE WHICH ALTERED A CAPACITOR VALUE WAS IMPLEMENTED TO PREVENT EXPOSURE SWITCH OVERLOADING AND ARCING IN NOVEMBER 2006. INVESTIGATION DATE: 11/04/2009. INVESTIGATION: THE RETURNED DISPLAY BOARD, MANUFACTURED IN FEBRUARY 2005, WAS EXAMINED. UPON EXAMINATION, THE S1 TACT SWITCH WAS FOUND TO BE NOT FUNCTIONING - SWITCH REMAINS IN THE "ON" POSITION AND CANNOT RETURN TO THE OPEN STATE AFTER RELEASE. BY DISASSEMBLING THE SWITCH, IT WAS OBSERVED THAT THE MOVEABLE METAL CONTACT INSIDE THE SWITCH WAS COLLAPSED AND SPLIT IN THE MIDDLE. THIS CONDITION RESULTED IN THE TACT SWITCH REMAINING IN THE "ON" POSITION PREVENTING THE RETURN TO AN OPEN STATE. THEREFORE, WHENEVER THE X-RAY UNIT IS POWERED ON, IT AUTOMATICALLY EXPOSES ONCE AND NO ADDITIONAL EXPOSURE CAN BE MADE SINCE THE S1 SWITCH, OR EXPOSURE SWITCH, IS IN THE "ON" POSITION ALL THE TIME. UNDER MICROSCOPE EXAMINATION, BLACK CARBON DEBRIS WAS OBSERVED ON THE PLASTIC FEATURES IMMEDIATELY NEXT TO THE SPLIT METAL CONTACT. THE S1 SWITCH WAS FURTHER DISASSEMBLED AND THE UNDERSIDE OF THE METAL CONTACT SHOWS A BLACK BURN MARK. THE BLACK BURN MARK IS INDICATIVE OF THE S1 SWITCH BEING SUBJECT TO SPONTANEOUS OVERLOAD WHICH CAN CAUSE ARCING. THE REPEATED ARCING ATE AWAY A SIGNIFICANT AMOUNT OF MATERIAL ON THE UNDERSIDE OF THE CONTACT WHICH RESULTED IN THE FATIGUE/CRACK. A DESIGN CHANGE WHICH ALTERED A CAPACITOR VALUE WAS IMPLEMENTED TO PREVENT THIS CONDITION IN NOVEMBER 2006.

    Description of Event or Problem · 1

    A SERVICE TECHNICIAN FROM THE DISTRIBUTOR REPORTED THAT A JB-70 INTRA-ORAL X-RAY UNIT, (B) (4), WOULD GENERATE AN EXPOSURE ON ITS OWN WHEN THE UNIT WAS TURNED ON. IT WAS DUE TO A MALFUNCTIONING PUSH BUTTON ON THE DISPLAY BOARD. THE SYSTEM COULD NOT MAKE ADDITIONAL EXPOSURE UNLESS IT'S POWERED OFF AND ON AGAIN. THE DENTAL ASSISTANT OF THE DENTAL OFFICE, (B) (6), POWERED ON/OFF THE UNIT 9 TIMES BEFORE CONTACTING THE SERVICE TECHNICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGENY JB-70 EHD MIDMARK CORPORATION JB-70

    Patients

    Seq Age Sex Outcome Treatment
    1