BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GX-770

    MDR report key: 6388452 · Received March 8, 2017

    Report

    Report Number
    2530069-2017-00007
    Event Type
    Malfunction
    Date Received
    March 8, 2017
    Date of Event
    February 7, 2017
    Report Date
    February 7, 2017
    Manufacturer
    GENDEX DENTAL SYSTEMS
    Product Code
    EHD
    PMA / PMN Number
    K935046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    DENTAL ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS MANUFACTURED IN MARCH OF 1991 AND HAS BEEN IN THE FIELD FOR OVER 25 YEARS. THE MODEL WAS DISCONTINUED IN MARCH OF 2010. THE DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER FOR FURTHER EVALUATION BECAUSE THE CUSTOMER RE-ATTACHED THE TUBE HEAD AND ELECTED TO KEEP THE DEVICE. THE CUSTOMER INDICATED THAT THE DEVICE HAD NOT BEEN MAINTAINED IN ACCORDANCE WITH THE DEVICE LABELING. THE GX-770 USER MANUAL (415-0169) STATES THAT IN THE INTEREST OF EQUIPMENT SAFETY, A MAINTENANCE PROGRAM MUST BE ESTABLISHED BY THE DEVICE OWNER AND PERIODIC MAINTENANCE PERFORMED BY FULLY QUALIFIED PERSONNEL ON AN ANNUAL BASIS. THIS CONCLUDES OUR INVESTIGATION.

    Description of Event or Problem · 1

    THE OPERATOR WAS POSITIONING THE DEVICE FOR A SCAN WHEN THE TUBE HEAD BECAME DISLODGED AND FELL ON THE PATIENT. THE PATIENT SUSTAINED A CUT TO THE UPPER LIP AND REDNESS OF THE SKIN (ERYTHEMA) WHERE THE TUBE HEAD MADE CONTACT. THE PATIENT DID NOT SEEK MEDICAL ATTENTION AND NO SERIOUS INJURY HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171406 GX-770 EXTRAORAL SOURCE X-RAY SYSTEM EHD GENDEX DENTAL SYSTEMS GX-770

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR