BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENDEX GX-770

    MDR report key: 3745445 · Received January 24, 2014

    Report

    Report Number
    2530069-2014-00001
    Event Type
    Malfunction
    Date Received
    January 24, 2014
    Date of Event
    January 2, 2014
    Report Date
    January 2, 2014
    Manufacturer
    GENDEX CORP
    Product Code
    EHD
    PMA / PMN Number
    K935046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS IN THE FIELD FOR MORE THAN 15 YEARS. THE DEVICE WAS NOT MADE AVAILABLE TO THE MANUFACTURER FOR FURTHER DIAGNOSIS. THE DEVICE WAS EVALUATED AND REPAIRED BY THE DISTRIBUTOR AT THE CUSTOMER'S SITE USING CUSTOMER-PROVISIONED REPLACEMENT PARTS. THIS MODEL WAS DISCONTINUED IN 2010 AND NO LONGER MANUFACTURED OR DISTRIBUTED. THIS CONCLUDES OUR INVESTIGATION.

    Description of Event or Problem · 1

    THE TUBEHEAD OF THE DEVICE FELL OFF THE ARM AND HUNG BY THE WIRES. THE DEVICE WAS NOT BEING USED ON PATIENTS AT TIME OF INCIDENT, THERE WERE NO INJURY TO PATIENT NOR OFFICE STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57486 GENDEX GX-770 EXTRAORAL SOURCE X-RAY SYSTEM EHD GENDEX CORP GX-770

    Patients

    Seq Age Sex Outcome Treatment
    1