BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIAGNODENT CLASSIC

    MDR report key: 9680461 · Received February 7, 2020

    Report

    Report Number
    3003637274-2015-00005
    Event Type
    Malfunction
    Date Received
    February 7, 2020
    Date of Event
    March 3, 2015
    Report Date
    March 24, 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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    BATTERY RECEIVED WAS SEND TO MANUFACTURER FOR EVALUATION. TILL NOW NO ADDITIONAL OR SIMILAR CASES ARE KNOWN. BASED ON CURRENT INFORMATION WE CONSIDER THE ISSUE AS A SINGLE CASE. FINAL REPORT WILL FOLLOW AS SOON THE EVALUATION ARE COMPLETE.

    Description of Event or Problem · 1

    DURING CHARGING PROCESS THE BATTERY GOT HOT AND STARTED MELTING. ASSISTANT TOOK BATTERY PACK OUT OF THE OFFICE, LATER THAN THE BATTERY PACK STARTED TO BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147833 DIAGNODENT CLASSIC CARIES DETECTOR NBL KAVO DENTAL GMBH KAVO DIAGNODENT 2095

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown