BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENDEX GX-770

    MDR report key: 4101966 · Received September 15, 2014

    Report

    Report Number
    2530069-2014-00008
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    August 17, 2014
    Report Date
    August 14, 2014
    Manufacturer
    GENDEX CORP.
    Product Code
    EHD
    PMA / PMN Number
    K935046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS MANUFACTURED IN JANUARY 2006 AND WAS IN SERVICE IN THE FIELD FOR 8 YEARS. THE CUSTOMER CLAIMED THAT PERIODIC MAINTENANCE WAS PERFORMED ANNUALLY ON THE DEVICE. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION ON (B)(4) 2014. BASED UPON THE VISUAL INSPECTION OF THE RETURNED PARTS, THE TUBEHEAD AND YOKE WERE RECEIVED DETACHED FROM THE ARTICULATING ARM. THE CAUSE OF THE DETACHMENT WAS ATTRIBUTED TO THE SET SCREW DISENGAGEMENT WHOSE FUNCTION WAS TO SECURE THE PIVOT ROD TO THE ARM. THERE WERE IMPRESSIONS ON THE RETURNED PARTS TO SUGGEST THAT THE SET SCREW WAS PROPERLY ENGAGED PREVIOUSLY. ALTHOUGH THE EXACT CAUSE FOT HE FAILURE CANNOT BE DETERMINED, A PROBABLE CAUSE IS HUMAN ERROR FOR NOT ENSURING PROPER POSITIONING OF THE SET SCREW DURING ROUTINE MAINTENANCE. THIS CONCLUDES THE INVESTIGATION FOR THIS INCIDENT.

    Description of Event or Problem · 1

    THE DENTAL ASSISTANT WAS POSITIONING THE DEVICE TO TAKE X-RAY ON A PATIENT WHEN THE TUBEHEAD BECAME DISLODGED AS THE ASSISTANT WAS PULLING IT. THE DENTAL ASSISTANT CAUGHT THE TUBEHEAD. NEITHER THE DENTAL ASSISTANT NOR THE PATIENT RECEIVED INJURY FROM THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569167 GENDEX GX-770 DENTAL EXTRA ORAL SOURCE X-RAY UNIT EHD GENDEX CORP. GX-770

    Patients

    Seq Age Sex Outcome Treatment
    1