BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIAGNODENT CLASSIC

    MDR report key: 4889794 · Received July 3, 2015

    Report

    Report Number
    3003637274-2015-00013
    Event Type
    Malfunction
    Date Received
    July 3, 2015
    Date of Event
    June 4, 2015
    Report Date
    June 5, 2015
    Manufacturer
    KAVO DENTAL GMBH
    Product Code
    NBL
    PMA / PMN Number
    K983658
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVALUATION PERFORMED BY AN INDEPENDENT INSTITUTE SHOWED THAT THE ORIGIN OF THE HEAT MUST BE FROM A SINGLE BATTERY CELL WITHIN THE BATTERY PACK WHICH GOT TOO HOT. ACCORDING TO THE INSTITUTE IT IS NOT POSSIBLE TO IDENTIFY THE ROOT CAUSE FOR THE OVERHEATING OF A SINGLE CELL AS THERE ARE VARIOUS POSSIBILITIES LIKE: FAILURE IN THE CELL DUE TO A HIT, E.G. FROM DROPPING, INACCURATE WELDING POINT ON ONE POLE AND THEREFORE A HIGHER CONTACT RESISTANCE, EXHAUSTIVE DISCHARGE OF A SINGLE CELL AND FURTHER POSSIBILITIES. BESIDE THE ISSUE WE REPORTED WITH MDR 3003637274-2015-00005 (IN THIS CASE IT WAS A DEFECT DUE TO DROPPING OF THE BATTERY PACK) WE ARE NOT AWARE OF FURTHER BURNING ISSUES. AS THERE ARE MORE THAN (B)(4) BATTERY PACKS DELIVERED AND ONLY (B)(4) INCIDENTS ARE KNOWN IT IS VERY LIKELY THAT ALSO THIS SECOND INCIDENT IS CAUSED BY A HANDLING FAILURE. THEREFORE THE CONCLUSION CODE IS SELECTED CORRESPONDINGLY. THE USER INSTRUCTION CONTAINS A NOTE THAT RECHARGEABLE BATTERIES MUST NOT BE DROPPED OR RECEIVED HITS FROM OTHER SOURCES.

    Additional Manufacturer Narrative · 1

    AS IT IS NOT POSSIBLE TO SEND THE CHARGEABLE BATTERY PACK BACK TO THE VENDOR IN (B)(4) FOR EVALUATION WE CONSULTED AN INDEPENDENT INSTITUTE TO ANALYZE SOME CHARGEABLE BATTERY PACK OUT OF THE SAME PRODUCTION PERIOD TO VERIFY THAT THEY MEET SPECIFICATION. THE PROCESS IS STARTED AND TAKES AT LEAST ADDITIONAL 3 WEEKS. AS SOON AS WE HAVE A RESULT WE WILL ISSUE A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    ACCORDING TO INFORMATION FROM DENTAL OFFICE THE BATTERY PACK WAS GETTING HOT WHILE IN USE ON THE DIAGNODENT CARIES DETECTOR. DOCTOR REMOVED THE BATTERY PACK FROM THE DIAGNODENT, THEN IT STARTED TO SPARK AND CAUGHT FIRE. NOBODY WAS INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433341 DIAGNODENT CLASSIC CARIES DETECTOR NBL KAVO DENTAL GMBH KAVO DIAGNODENT 2095

    Patients

    Seq Age Sex Outcome Treatment
    1