BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOCUS

    MDR report key: 15907048 · Received December 2, 2022

    Report

    Report Number
    3005383085-2022-00003
    Event Type
    Malfunction
    Date Received
    December 2, 2022
    Date of Event
    November 4, 2022
    Report Date
    December 2, 2022
    Manufacturer
    PALODEX GROUP OY
    Product Code
    EHD
    UDI-DI
    06430035872695
    PMA / PMN Number
    K001729
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE UNIT INVESTIGATION WAS COMPLETED ON 1/13/2023. A BROKEN TUBEHEAD PROTECTIVE EARTHING CABLE WAS DISCOVERED, WHEREBY TWO (2) STRANDS WERE BROKEN. THERE IS NO EVIDENCE OF THE CAUSE OF THE BROKEN STRANDS. THE ELECTRICAL SAFETY TEST WAS RUN FOR THE DEVICE IN PRODUCTION. ALL TEST CASES WERE PASSED EXCEPT THE TUBEHEAD ARM EARTH RESISTANCE TEST DUE TO BROKEN PE WIRE. EVEN WITH BROKEN WIRE, THE TUBEHEAD ARM EARTH RESISTANCE WAS STILL ONLY 101MOHM, WHILE THE HIGHEST ALLOWED VALUE IN PRODUCTION IS 90MOHM. THE SAFETY STANDARD 60601-1 ALLOWS 100MOHM RESISTANCE. ALL OTHER CABLES, CABLE JOINTS AND CONNECTORS WERE IN GOOD CONDITION, WITH NO SIGNS OF CORROSION, SPARKING OR BURN ANYWHERE ON THE DEVICE. THE REPORTED PROBLEM I.E. ELECTRIC SHOCK WAS NOT REPEATABLE AND NO REASON WAS FOUND THAT COULD HAVE CAUSED THE ELECTRIC SHOCK. BASED ON THE INVESTIGATIONS THE PRODUCT HAS STAYED SAFE DESPITE THE BROKEN PE WIRE. THIS CONCLUDES THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    A DEALER TECHNICIAN WAS ON SITE 11/7/2022 AT THE DOCTOR'S OFFICE AND CHECKED THE UNIT FOR VISUAL EVIDENCE OF A POSSIBLE ELECTRICAL SHORT (SCORCH MARKS), AND FOR ANY EXPOSED WIRES ON THE UNIT. THERE WERE NO EVIDENCE OF AN ELECTRICAL SHORT, NOR ANY EXPOSED WIRES FOUND. THE DEALER TECHNICIAN TOOK MULTIPLE EXPOSURES, WHEREBY NO ERRORS OR MALFUNCTION OCCURRED. ON 11/17/2022 A DENTAL IMAGING TECHNOLOGIES CORPORATION (DITC) TECHNICIAN (INITIAL IMPORTER) VISITED THE DOCTOR'S OFFICE TO TAKE PHOTOS OF THE DEVICE AND PERFORM ADDITIONAL TESTING. THE INCOMING VOLTAGE TO THE UNIT WAS CONSTANT. IN REVIEW OF THE PHOTOS, TWO EXPOSED WIRES WERE OBSERVED. TUBE HEAD GROUND WIRE. SCISSOR ARM CABLE WHERE IT MEETS THE HORIZONTAL ARM. THE TECHNICIAN DID NOT SEE ANY OTHER CABLE DAMAGE INSIDE THE SCISSOR OR HORIZONTAL ARM, OR ON THE GENERATOR BOARD. THE STAFF MEMBER WHO REPORTED BEING SHOCKED WAS NOT IN THE OFFICE DURING THIS VISIT, THUS THE ACTUAL LOCATION OF WHERE THE REPORTED SPARK OCCURRED COULD NOT BE CONFIRMED. THE UNIT WAS BEING USED AT TIME OF THIS VISIT AND THE DITC TECHNICIAN ADVISED THE MANAGER TO DISCONTINUE USE OF THE UNIT, AND APPLIED APPROPRIATE SIGNAGE ON THE UNIT. THE UNIT WILL BE RETURNED TO THE MANUFACTURER FOR FURTHER INVESTIGATION, WHEREBY A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY A DENTAL OFFICE THAT A STAFF MEMBER RECEIVED A SHOCK FROM THE UNIT WHILE PREPARING FOR CLINICAL USE. STAFF REPORTED SEEING A WHITE SPARK/ FLASH FROM THE BACK OF THE HORIZONTAL ARM WHERE IT MEETS THE WALL. NO INJURIES OR MEDICAL ATTENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1797717 FOCUS EXTRAORAL SOURCE X-RAY SYSTEM EHD PALODEX GROUP OY 0.805.9510 06430035872695

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown