BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E500 VENTILATOR

    MDR report key: 2929650 · Received January 17, 2013

    Report

    Report Number
    2023050-2013-00043
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    December 24, 2012
    Report Date
    December 27, 2012
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K061094
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THOUGH REQUESTED, NO PT INFO WAS PROVIDED.

    Description of Event or Problem · 1

    DURING PT USE, "GDM COM FAILURE" ERROR MESSAGE DISPLAYED ON THE SCREEN AND THE VENTILATOR ALARMED. AFTER THE STAFF POWERED THE VENTILATOR OFF AND BACK ON AGAIN, THE ERROR MESSAGE AND THE ALARM ACTIVATED AGAIN. THE PT WAS SWITCHED TO ANOTHER VENTILATOR. NO PT INJURY WAS REPORTED IN THIS CASE. LATER, DISTRIBUTOR WAS UNABLE TO DUPLICATE THE ISSUE; THE VENTILATOR WORKED NORMALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26408 E500 VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS, INC. E500

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention