BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3003637274-2016-00010

    MDR report key: 5446616 · Received February 19, 2016

    Report

    Report Number
    3003637274-2016-00010
    Event Type
    Malfunction
    Date Received
    February 19, 2016
    Date of Event
    January 21, 2016
    Report Date
    January 21, 2016
    PMA / PMN Number
    K983658
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    DENTAL ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANALYSIS OF THE CHARGEABLE BATTERY PACK SHOWED THAT THE HOUSING WAS CRACKED AND TAPED TOGETHER AGAIN. ALSO A SMALL GRAFTER OF THE HOUSING WAS MISSING. THE ONLY EXPLANATION FOR THIS CONDITION IS THAT THE BATTERY PACK HAS BEEN DROPPED (WHICH CAUSED THE CRACK) AND PUT TOGETHER AGAIN ON THE USERS SITE. SEPARATING THE 2 HOUSING PARTS SHOWED THAT AN ISOLATING FOIL WAS DISPLACED. THEREFORE A CONDUCTOR WHICH IS NORMALLY COMPLETELY ISOLATED AND RUNS ACROSS SEVERAL SINGLE CELLS HAD NOW CONTACT TO THIS CELLS WHICH CAUSED A DIRECT SHORT-CIRCUIT. IN CONSEQUENCE THE CONDUCTOR WAS OVERLOADED AT THIS POINTS, GOT HOT AND STARTED TO MELT. THIS WAS ENOUGH HEAT THAT THE HOUSING WAS ALSO MELTING. ROOT CAUSE FOR THE DISLOCATION OF THE ISOLATION FOIL WAS, THAT THE PERSON WHO PUT THE 2 HOUSING PARTS BACK TOGETHER AFTER THE DROP PUSHED THE ISOLATION FOIL BY MISTAKE DEEPER INTO THE HOUSING. BY CLOSING AND TAPING THE 2 HOUSINGS THE ISOLATION FOIL HAS BEEN PRESSED DEEPER AND DEEPER INSIDE THE BATTERY PACK AND THE CONDUCTOR HAS BEEN PRESSED ON THE CONTACTS OF THE SINGLE BATTERY CELLS. THE USER INSTRUCTION CONTAINS A CLEAR NOTE WHICH STATES THAT THE BATTERY PACK: * MUST NOT BE MODIFIED OR DISASSEMBLED * MUST NOT BE DROPPED OR GET SHOCKS.

    Description of Event or Problem · 1

    DESCRIBED IS THAT THE CHARGEABLE BATTERY PACK CAUGHT FIRE AFTER THE DENTAL ASSISTANT REMOVED IT FROM THE DIAGNODENT IN ORDER TO CHARGE IT. SHE THREW IT IN THE SNOW. NOBODY WAS INJURED. THERE WAS NO PATIENT INVOLVED HENCE THERE ARE NO DATA ENTERED.

    Patients

    Seq Age Sex Outcome Treatment
    1