BEUDAMED
    FDA Enforcement Class I Terminated

    e500 Automatic Transport Ventilator, Model Number 01EVE500

    Recall: Z-0976-2019 · Reported April 10, 2019

    Enforcement

    Recall Number
    Z-0976-2019
    Event ID
    82178
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    O-Two Medical Technologies, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 10, 2019
    Initiation Date
    February 12, 2019
    Classification Date
    April 4, 2019
    Termination Date
    June 29, 2023
    Address
    45A Armthorpe Road, N/A, Brampton, Ontario, N/A, Canada

    Description

    e500 Automatic Transport Ventilator, Model Number 01EVE500

    Reason

    There is a potential for the unit to catch fire due to one of the screen retaining screws being incorrectly inserted. Due to this improper screw insertion the screw sat higher than normal allowing it to contact the underside of the main board causing the screw to rub against the bottom side of the board, wearing away the insulation layer and creating a short circuit.

    Code Info

    EV50001 to EV50148

    Distribution

    The products were distributed to the following US states: AZ, CA, CO, FL, OH, PA, TX, and VA.

    Quantity

    136