BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOBII

    MDR report key: 3253581 · Received June 3, 2013

    Report

    Report Number
    3007873415-2013-00003
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    November 22, 2011
    Report Date
    May 14, 2013
    Manufacturer
    TOBII TECHNOLOGY AB
    Product Code
    MOQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING A REVIEW OF THE P10 BATTERY BOX, WE IDENTIFIED A POTENTIAL CONCERN. UNDER EXCEPTIONAL CONDITIONS, WHEN USING BATTERIES BEYOND THEIR EXPECTED LIFE TIME, THERE IS A SMALL RISK DURING THE CHARGING CYCLE THAT THE BATTERIES CAN SHORT CIRCUIT, SINCE BATTERIES ARE VENTING GAS THIS COULD EVENTUALLY LEAD TO A GAS EXPLOSION AND/OR FIRE. THE RISK IS SMALL. ONE INCIDENT OF SWOLLEN AND DEGRADING BATTERIES NOT CAUSING DAMAGE HAS COME TO OUR ATTENTION OUT OF (B)(4) BATTERY BOXES SHIPPED. HOWEVER TOBII ATI HAS REPORTED THIS INCIDENT TO THE FDA, FOOD AND DRUG ADMINISTRATION PRODUCT SAFETY COMMISSION AND REGULATORY AUTHORITIES IN THE EC, AND TAKEN A PRECAUTIONARY ACTION TO INFORM ALL USERS OF THE P10 BATTERY BOX ON HOW TO SECURE THAT THE BATTERIES ARE SAFE TO USE.

    Description of Event or Problem · 1

    ON (B)(6) 2011 CUSTOMER CALLED TOBII ATI TO COMPLAIN THAT THEIR BATTERY CHARGE LASTED ONLY 2 HOURS. THE PRODUCT WAS RETURNED TO TOBII ATI FOR INVESTIGATION. BATTERIES WERE FOUND TO BE SWOLLEN AND LEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245596 TOBII P-10 BATTERY PACK MOQ TOBII TECHNOLOGY AB T510410

    Patients

    Seq Age Sex Outcome Treatment
    1