BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENDEX GX-770

    MDR report key: 4101965 · Received September 15, 2014

    Report

    Report Number
    2530069-2014-00007
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    August 15, 2014
    Report Date
    August 15, 2014
    Manufacturer
    GENDEX CORP.
    Product Code
    EHD
    PMA / PMN Number
    K935046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS MANUFACTURED IN AUGUST 1002 AND WAS IN SERVICE IN THE FIELD FOR 22 YEARS. THE CUSTOMER INDICATED THAT A DRIFTING OF THE ARM ASSEMBLY WAS NOTICED SEVERAL WEEKS PRIOR TO THE INCIDENT, ALONG WITH A SMALL CRACK IN THE ASSEMBLY, WHICH WAS IGNORED. THE TECHNICIAN CLAIMED THAT THE UNIT WAS SERVICED PERIODICALLY ALTHOUGH THERE WAS NO DOCUMENTED EVIDENCE FOUND FOR MAINTENANCE. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION ON (B)(4) 2014. IT WAS NOTICED THAT THE HORIZONTAL ARM WAS BROKEN AT THE INNER PIVOT HOUSING, WHICH CAUSED THE UNIT TO SEPARATE FROM THE HORIZONTAL ARM TO THE MAIN CONVERTER. THE LIKELY CAUSE OF THE FAILURE WAS THE PROLONGED SERVICE OF THE UNIT BEYOND THE END OF THE LIFE. THIS CONCLUDES THE INVESTIGATION RELATED TO THIS INCIDENT.

    Description of Event or Problem · 1

    THE DOCTOR WAS POSITIONING THE DEVICE TO TAKE X-RAY ON A PATIENT WHEN THE HORIZONTAL ARM, THE ARTICULATED ARM AND THE TUBE HEAD BECAME DISLODGED FROM THE CONVERTER. THE DOCTOR CAUGHT THE DEVICE IN HIS ARMS. NEITHER THE DOCTOR NOR THE PATIENT RECEIVED INJURY FROM THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569315 GENDEX GX-770 DENTAL EXTRA ORAL SOURCE X-RAY UNIT EHD GENDEX CORP. GX-770

    Patients

    Seq Age Sex Outcome Treatment
    1