BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGENY JB-70

    MDR report key: 1942002 · Received November 8, 2010

    Report

    Report Number
    1423380-2010-00034
    Event Type
    Malfunction
    Date Received
    November 8, 2010
    Date of Event
    October 12, 2010
    Report Date
    November 8, 2010
    Manufacturer
    MIDMARK CORPORATION
    Product Code
    EHD
    PMA / PMN Number
    K020070
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 (B)(4) 2007.

    Description of Event or Problem · 1

    A SERVICE TECHNICIAN FROM A DEALER 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 MALFUNCTION PUSH BUTTON ON THE DISPLAY BOARD. THE SYSTEM COULD NOT MAKE ADDITIONAL EXPOSURE UNLESS IT'S POWERED OFF AND ON AGAIN.

    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