BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENDEX 765 DC

    MDR report key: 3022950 · Received March 20, 2013

    Report

    Report Number
    2530069-2013-00005
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 25, 2013
    Report Date
    February 25, 2013
    Manufacturer
    GENDES DENTAL SYSTEMS
    Product Code
    EHD
    PMA / PMN Number
    K992610
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT SAFETY MANAGER FROM USER FACILITY RELAYED THE INFO THAT THE PT SUSTAINED A NON-SKIN BREAKING CONTUSION AND A HEADACHE AFTER BEING HIT BY THE TUBE HEAD IN THE HEAD AND SHOULDER. HE WAS SEEN BY A PROVIDER ON-SITE IMMEDIATELY AND WAS PRESCRIBED TYLENOL FOR THE HEADACHE; HE HAD FULL RANGE OF MOTION IN HIS SHOULDER. THE PT WAS INFORMED OF SIGNS AND SYMPTOMS OF INTERNAL BLEEDING AND CONCUSSION BUT DID NOT SEEK NOR REQUIRE FOLLOW UP VISITS, HE HAS RECOVERED FULLY. THE DEVICE HAS BEEN IN SVC FOR 7 YEARS. IT WAS REC'D AT THE MFR'S REPAIR CTR ON (B)(4) 2013 AND THE EVALUATION HAS BEEN COMPLETED. THE EVIDENCE FROM THE RETURNED PARTS SUGGEST THAT THE TOP BOLT SECURING THE DEVICE TO THE WALL PLATE BECAME LOOSE FROM THE WALL, SO THAT ALL OF THE WEIGHT OF THE CONVERTER CHASSIS WAS RESTING SOLELY ON THE LOWER BOLT WHICH, WITH CONTINUED USE, CAUSED THE CONVERTER CHASSIS ASSEMBLY TO BREAK OFF THE MOUNTING PLATE. THE TOP BOLT DID NOT APPEAR TO BE STRIPPED OR DEFORMED, INDICATING IT DID NOT FAIL MECHANICALLY. IT DID BECOME LOOSE THROUGH SOME UNK MEANS. IT IS POSSIBLE IT WAS ABLE TO WORK ITSELF LOOSE UNDER NORMAL MOVEMENT OF THE ARM AND/OR SOME EXTERNAL VIBRATION IN THE ENVIRONMENT. IT IS ALSO POSSIBLE THE TOP BOLT WAS NOT SUFFICIENTLY TIGHTENED AT INSTALLATION, AND ULTIMATELY WORKS LOOSE AFTER ITS TIME IN SVC AND CAUSES THE FAILURE AS DESCRIBED ABOVE. IN THE INSTALLATION MANUAL FOR 765-DC, THE REQUIRED TOOLS FOR INSTALLATION AND THE WALL SUPPORT REQUIREMENTS WERE SPECIFIED. IN THE USER MANUAL FOR 765-DC, MOUNTING CHECK IS PART OF THE ANNUAL RECOMMENDED MAINTENANCE. THE MODEL WAS DISCONTINUED IN AUGUST 2007. THIS CONCLUDES OUR INVESTIGATION.

    Description of Event or Problem · 1

    THE DEVICE (WALL-MOUNTED) FELL OFF THE WALL WHEN IT WAS BEING POSITIONED TO TAKE AN X-RAY ON A PT: THE TUBE HEAD HIT A PT IN THE HEAD AND SHOULDER. THE PT GOT A BRUISE ON THE HEAD AND A HEADACHE. HE WAS SEEN BY A PROVIDER ON-SITE, AND WAS PRESCRIBED TYLENOL. THE PT RECOVERED FULLY AND DID NOT REQUIRE FOLLOW UP VISITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116218 GENDEX 765 DC INTRAORAL DENTAL X-RAY SYSTEM EHD GENDES DENTAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention