BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENDEX EXPERT DC INTRAORAL X-RAY SYSTEM

    MDR report key: 2022722 · Received March 17, 2011

    Report

    Report Number
    3004115000-2011-00006
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 17, 2011
    Manufacturer
    GENDEX DENTAL SYSTEMS
    Product Code
    EHD
    PMA / PMN Number
    K992610
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATED INFORMATION WAS OBTAINED FROM THE DEALER SERVICE TECHNICIAN FROM THE RE-INSTALLATION OF THE UNIT. FOR THE ORIGINAL INSTALLATION THE UNIT WAS NOT MOUNTED WITH THE OPTIONAL 16" WALL PLATE. THE UNIT WAS INSTALLED TO THE WALL WHICH CONTAINED TWO 5/8TH SHEETS OF PLYWOOD, ONE ON TOP OF THE OTHER, SANDWICHED BETWEEN THE 2X4 STUDS. THE UPPER AND LOWER LAG BOLTS WERE SCREWED INTO THE PLYWOOD. THE TOP LAG BOLT PULLED OUT OF THE PLYWOOD CAUSING THE INCIDENT OF THE UNIT FALLING OFF THE WALL DURING USE. THE UNIT WAS REPAIRED AND RE-INSTALLED BY THE DEALER SERVICE TECHNICIAN USING A 16" WALL PLATE MOUNTED TO THE 2X4 STUDS ON 16" CENTER.

    Additional Manufacturer Narrative · 1

    THE ASSISTANT BUMPED HER HAND ON THE CHAIR WHEN CATCHING THE UNIT AS IT FELL. DURING A FOLLOW-UP WITH THE OFFICE, IT WAS CONFIRMED THAT THE ASSISTANT'S HAND WAS FINE. NO MEDICAL TREATMENT WAS NEEDED. THE TOP LAG BOLT PULLED OUT OF THE WALL PUTTING THE WEIGHT FORCE OF THE X-RAY UNIT ON THE BOTTOM LAG CAUSING THE CASTING AT THE BOTTOM LAG MOUNT TO BREAK ALLOWING THE UNIT TO FALL. DURING A FOLLOW-UP CALL WITH THE DEALER SERVICE TECHNICIAN, HE STATED THAT THERE WAS NO APPARENT REASON WHY THE TOP LAG PULLED OUT, THEY WERE USING 1.5" BACKING ON A SINGLE STUD MOUNT AND THE LAGS APPEARED TO BE DRILLED IN THE CENTER OF THE 2X4 STUD. LABELING PROVIDED WITH THE X-RAY UNITS INSTRUCTS THE INSTALLERS TO VERIFY THE WALL SUPPORT CAPABILITY PRIOR TO INSTALLATION. IN CONCLUSION, THIS WAS AN INSTALLATION ISSUE AND NOT A MALFUNCTION OF THE X-RAY UNIT. THE X-RAY UNIT WAS REPAIRED AND RE-INSTALLED BY THE DEALER SERVICE TECHNICIAN THE DAY FOLLOWING THE INCIDENT. DEVICE REPAIRED BY DEALER SERVICE TECH.

    Description of Event or Problem · 1

    THE X-RAY UNIT FELL FROM THE WALL DURING USE AND WAS CAUGHT BY THE ASSISTANT WHEN IT FELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENDEX EXPERT DC INTRAORAL X-RAY SYSTEM DENTAL X-RAY EQUIPMENT EHD GENDEX DENTAL SYSTEMS EXPERT DC

    Patients

    Seq Age Sex Outcome Treatment
    1