BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGENY JB-70

    MDR report key: 1424985 · Received April 29, 2009

    Report

    Report Number
    1423380-2009-00003
    Event Type
    Malfunction
    Date Received
    April 29, 2009
    Date of Event
    April 2, 2009
    Report Date
    April 24, 2009
    Manufacturer
    PROGENY
    Product Code
    MUH
    PMA / PMN Number
    K 020070
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    A DENTAL PROFESSIONAL, THROUGH A DEALER SERVICE TECHNICIAN, REPORTED THAT THE EXPOSURE CONTROL ON A JB-70 INTRAORAL X-RAY WOULD "FIRE ON ITS OWN" WHEN THE ARM WAS MOVED. PROGENY TECHNICAL SERVICE ADVISED THE UNIT, BE UNPLUGGED AND REMOVED FROM SERVICE. A PROGENY TECHNICAL SERVICE REPRESENTATIVE FLEW TO THE DENTAL OFFICE TO EVALUATE THE UNIT AND FOUND THAT THE CABLE CONNECTING TO THE REMOTE SWITCH HAD BEEN STRIPPED AND TWO OF THE WIRES WERE SHORTED OUT CAUSING THE UNIT TO RADIATE WHEN MOVED. THE CABLE WAS NOT MANUFACTURED OR INSTALLED BY PROGENY. THE CABLE WAS REPLACED AND THE JB-70 INTRAORAL UNIT FUNCTIONED PER SPECIFICATION. THE DOCTOR WAS ALERTED OF THE ROOT CAUSE, AS WAS THE DEALER SERVICE TECHNICIAN WHO WAS PRESENT DURING THE EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGENY JB-70 MUH PROGENY JB-70

    Patients

    Seq Age Sex Outcome Treatment
    1