BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOMAD PRO

    MDR report key: 15493728 · Received September 27, 2022

    Report

    Report Number
    3021551-2022-00001
    Event Type
    Malfunction
    Date Received
    September 27, 2022
    Date of Event
    August 4, 2022
    Report Date
    September 27, 2022
    Manufacturer
    DENTAL IMAGING TECHNOLOGIES CORPORATION
    Product Code
    EHD
    PMA / PMN Number
    K081664
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL EVALUATION SHOWS THE CONDITION OF THE UNIT WHILE IN THE FIELD. UPON VISUAL INVESTIGATION OF THE UNIT, IT WAS CONCLUDED THAT A THERMAL EVENT DID TAKE PLACE RESULTING IN THE APPEARANCE OF THE AFFECTED UNIT. THIS PARTICULAR DEVICE WAS NOT RETURNED TO DENTAL IMAGING TECHNOLOGIES CORPORATION AT TIME OF THIS REPORT. HOWEVER, A FOLLOW-UP REPORT WILL BE SUBMITTED, IF RETURNED AND INVESTIGATION COMPLETED. NOTE: THIS DEVICE AND ASSOCIATED MALFUNCTION WAS SUBJECT TO A CLASS 2 RECALL (Z-2016/2017-2016) AND WAS INITIATED BY THE ORIGINAL MANUFACTURER, KAVO DENTAL TECHNOLOGIES, LLC DBA ARIBEX LOCATED IN CHARLOTTE NC, ON APRIL 1, 2016. THE RECALL WAS INITIATED DUE TO POTENTIAL THERMAL EVENTS FROM BATTERIES IN THE DEVICE HANDSETS. THE RECALL WAS TERMINATED BY FDA ON JULY 26, 2017. THIS EVENT IS BEING REPORTED AS PART OF RECALL Z-2016/2017-2016 TO FULFILL REGULATORY REPORTING OBLIGATIONS UNDER 21 CFR PART 803 AND 806. ARIBEX NOTIFIED ALL CUSTOMERS OF THE RECALL WHILE THE RECALL WAS OPEN. THIS PARTICULAR CUSTOMER RECEIVED REPLACEMENT HANDSETS ON 8/9/2016 UNDER THE RECALL. NOTE: NOMAD DEVICE MANUFACTURING HAS BEEN MOVED FROM KAVO DENTAL TECHNOLOGIES, LLC DBA ARIBEX IN CHARLOTTE, NC TO DENTAL IMAGING TECHNOLOGIES CORPORATION IN QUAKERTOWN, PA IN JULY 2022.

    Additional Manufacturer Narrative · 0

    UPON VISUAL INSPECTION, A THERMAL EVENT DID OCCUR. WHILE ON THE CHARGING CRADLE, AN ARIBEX HANDSET MAY HAVE CAUSED THE THERMAL EVENT WHICH DAMAGED BOTH THE HANDSET AND CRADLE. IT IS NOT POSSIBLE TO DETERMINE THE EXACT CAUSE OF EVENTS THAT LED TO THE THERMAL EVENT. BASED ON PREVIOUS INVESTIGATIONS WITH THE SAME TYPE OF BATTERY, A SHORT MAY HAVE OCCURRED IN THE UPPER BATTERY PACK BETWEEN THE CELLS AND PCB. THIS BATTERY HAS PASSED ITS ESTABLISHED END OF LIFE. THE RECHARGEABLE BATTERIES LAST ABOUT 2-3 YEARS OR 300 CHARGE/DISCHARGE CYCLES, IF THEY HAVE BEEN USED PROPERLY. IN THIS CASE, THE BATTERY HAS BEEN IN USE FOR AT LEAST 6 YEARS. OVERCHARGING AND OVER-DISCHARGING OF THE BATTERIES CAN RESULT IN THE CELLS SWELLING AND ALLOWING EGRESS OF ELECTROLYTE WHICH MAY HAVE CAUSED OR CONTRIBUTED TOWARD THE REMOVAL OF THE SOLDER MASK MATERIAL ON THE PCB, CONTRIBUTING TO THE THERMAL EVENT. HOWEVER, IT IS NOT FEASIBLE TO DETERMINE THE CORRELATION OF THE THERMAL EVENT AND THE POTENTIAL ELECTROLYTE LEAKAGE. THE NOMAD PRO 2, WITH A NEWLY DESIGNED BATTERY AND HANDSET, WAS 510(K) CLEARED ON NOVEMBER 16, 2017. THE BATTERY AND HANDSETS SUBJECT OF THIS INVESTIGATION ARE NO LONGER DISTRIBUTED WITH NOMAD PRO 2.

    Additional Manufacturer Narrative · 0

    THE OPERATOR MANUAL SECTION 5 (HANDSET REPLACEMENT AND CARE) INSTRUCTS THE USER OF STEPS TO MAINTAIN THE HANDSET. THE SECTION "IMPORTANT HANDSET CARE NOTES" INDICATES "WHEN THE CHARGING CRADLE SENSES A BAD HANDSET BATTERY, THE INDICATOR LIGHTS WILL ILLUMINATE RED RATHER THAN GREEN. IN THIS CASE, THE BATTERIES ARE INOPERABLE AND MUST BE SERVICED.". UPON FURTHER FOLLOW-UP WITH THE END USER ON (B)(6) 2022, THE END USER INDICATED THE RED INDICATOR LIGHT PREVIOUSLY ILLUMINATED HOWEVER THEY CONTINUED TO USE THE HANDSET WITH BATTERY. THIS CONCLUDES THE INVESTIGATION.

    Description of Event or Problem · 0

    PER (B)(4): UNIT CAUGHT FIRE - CUSTOMER REPORTED A UNIT WAS STORED IN A CABINET ON ITS' CHARGER AND NOT IN USE WHEN THEY SMELLED SMOKE. UPON LOCATING THE SOURCE OF THE SMELL, AN ASSOCIATE OPENED THE STORAGE CABINET AND OBSERVED THE UNIT WAS ON FIRE. TWO (2) STAFF MEMBERS REPORTED HAVING A HEADACHE FROM THE SMOKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2303183 NOMAD PRO EXTRAORAL SOURCE X-RAY SYSTEM EHD DENTAL IMAGING TECHNOLOGIES CORPORATION 0.850.0009

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown