BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOMAD PRO

    MDR report key: 11317416 · Received February 11, 2021

    Report

    Report Number
    2530069-2021-00001
    Event Type
    Malfunction
    Date Received
    February 11, 2021
    Date of Event
    January 25, 2021
    Report Date
    February 11, 2021
    Manufacturer
    DENTAL IMAGING TECHNOLOGIES CORPORATION
    Product Code
    EHD
    PMA / PMN Number
    K081664
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EVALUATION SHOWS THE CONDITION OF THE UNIT RECEIVED FROM 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. INVESTIGATION OF THE UNIT REVEALED THAT THE THERMAL EVENT OCCURRED WHEN ELECTROLYTIC GAS SWELLED IN ONE OF THE TWO BATTERY CELLS IN THE HANDSET, CAUSING THE CELL TO BURST. THE SUBSEQUENT GAS DISCHARGE CAUSED A THERMAL EVENT TO OCCUR LEADING TO DAMAGE TO THE HANDSET. VISUAL INSPECTION RESULTS OF THE CHARGING CRADLE CONFIRMS THE CHARGING CRADLE WAS NOT THE SOURCE OF THE THERMAL EVENT. WHILE IT IS NOT POSSIBLE TO ASCERTAIN THE EXACT CHAIN OF EVENTS THAT LED TO THE THERMAL EVENT, EVIDENCE AND PRIOR INVESTIGATIONS INTO EVENTS OF THIS NATURE, SUGGESTS THAT GAS BUILD-UP IN THE BATTERY CELL(S) WAS RELEASED CAUSING A THERMAL EVENT. THE LOCATION OF THE THERMAL EVENT WITHIN THE HANDSET PRECLUDED DETERMINATION OF MANUFACTURE DATE OF THE BATTERY HANDLE ASSEMBLY. THE DATE OF MANUFACTURE FOR THE HANDSET ASSEMBLY WAS CONFIRMED FROM THE DEVICE HISTORY RECORD. THIS COMPLETES THE INVESTIGATION. THIS DEVICE AND ASSOCIATED MALFUNCTION WAS SUBJECT TO A CLASS 2 RECALL ((B)(4)) AND WAS INITIATED BY THE ORIGINAL MANUFACTURER, KAVO DENTAL TECHNOLOGIES, LLC DBA ARIBEX LOCATED IN (B)(4), ON (B)(6) 20.16 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. ARIBEX NOTIFIED ALL CUSTOMERS OF THE RECALL WHILE THE RECALL WAS OPEN. THIS PARTICULAR CUSTOMER DID NOT RESPONDED BACK TO ARIBEX FOLLOWING MULTIPLE ATTEMPTS, IN RESPONSE TO THE RECALL. THIS PARTICULAR DEVICE WAS RETURNED TO DENTAL IMAGING TECHNOLOGIES CORPORATION ON JANUARY 28, 2021 FOR COMPLAINT INVESTIGATION AND AS A RESULT THE HANDSET WAS REPLACED. NOTE: NOMAD DEVICE MANUFACTURING HAS BEEN MOVED FROM KAVO DENTAL TECHNOLOGIES, LLC DBA ARIBEX IN (B)(4) TO DENTAL IMAGING TECHNOLOGIES CORPORATION IN (B)(4) IN (B)(6) 2020.

    Description of Event or Problem · 1

    UNIT CAUGHT FIRE - NO INJURY OR DEATH. NO IMPACT TO PATIENT CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216368 NOMAD PRO EXTRAORAL SOURCE X-RAY SYSTEM EHD DENTAL IMAGING TECHNOLOGIES CORPORATION 0.850.0009

    Patients

    Seq Age Sex Outcome Treatment
    1