BEUDAMED
    FDA Adverse Event Other Summary report: N

    E360 VENTILATOR

    MDR report key: 1883302 · Received October 21, 2010

    Report

    Report Number
    2023050-2010-00045
    Event Type
    Other
    Date Received
    October 21, 2010
    Date of Event
    September 21, 2010
    Report Date
    September 24, 2010
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K053502
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    REPORTEDLY, THE VENTILATOR STOPPED VENTILATING WITH DEVICE ALERT ALONG WITH ERROR MESSAGE AND BLACK SCREEN DURING IN USE ON A PT. THE VENTILATOR WAS IMMEDIATELY POWERED OFF AND BACK ON AGAIN BY THE NURSE/RESPIRATORY THERAPIST WITHOUT FURTHER PROBLEMS. THE PT WAS AMBU BAGGED FOR A COUPLE OF MINUTES WHILE THE VENTILATOR WAS TURNING OFF/ON. PLEASE NOTE THAT THERE WAS NO PERMANENT INJURY IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 E360 VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS, INC. E360 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention