BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E360 VENTILATOR

    MDR report key: 2922038 · Received January 4, 2013

    Report

    Report Number
    2023050-2013-00011
    Event Type
    Injury
    Date Received
    January 4, 2013
    Date of Event
    December 15, 2012
    Report Date
    December 19, 2012
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS
    Product Code
    CBK
    PMA / PMN Number
    K053502
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THOUGH REQUESTED, PT INFO WAS NOT PROVIDED.

    Description of Event or Problem · 1

    REPORTEDLY, DURING PT USE, A "NO COMMUNICATION" ERROR OCCURRED. THE PT WAS MANUALLY VENTILATED AND SWITCHED TO ANOTHER VENTILATOR. THERE WERE NO ADVERSE PT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5481 E360 VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS E360

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention