BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIVONGO SCALE

    MDR report key: 8994548 · Received September 11, 2019

    Report

    Report Number
    3011196194-2019-00015
    Event Type
    Malfunction
    Date Received
    September 11, 2019
    Date of Event
    August 8, 2019
    Report Date
    September 6, 2019
    Manufacturer
    LIVONGO HEALTH
    Product Code
    FRI
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO INJURY TO THE USER WAS REPORTED. THE SCALE WAS RETURNED TO THE MANUFACTURER, AND AN INVESTIGATION WAS PERFORMED. A PHYSICAL INSPECTION OF THE SCALE WAS PERFORMED AND FOUND A SMALL HOLE IN THE BACK OF THE SCALE. INITIAL FUNCTIONAL TESTING FOUND THAT THE SCALE DID NOT TURN ON. ROOT CAUSE WAS DETERMINED TO BE A USABILITY ISSUE, IN WHICH THE BATTERIES WERE INSERTED INTO THE SCALE INCORRECTLY, CAUSING A CAPACITOR TO SHORT CIRCUIT.

    Description of Event or Problem · 1

    THE USER REPORTED THAT UPON BATTERY INSERTION THERE WAS A VISIBLE SPARK, AND A BURNING SMELL EMANATED FROM THE BATTERY COMPARTMENT. THE USER ALSO REPORTED THAT THE BATTERIES WERE WARM TO THE TOUCH AND A HOLE HAD MELTED IN THE BACK OF THE SCALE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793655 LIVONGO SCALE SCALE FRI LIVONGO HEALTH BT004L

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR