BEUDAMED
    FDA Adverse Event Other Summary report: N

    E360 VENTILATOR

    MDR report key: 2217292 · Received July 12, 2011

    Report

    Report Number
    2023050-2011-00029
    Event Type
    Other
    Date Received
    July 12, 2011
    Date of Event
    May 24, 2011
    Report Date
    June 13, 2011
    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
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR WAS VENTILATING THE PT AND FUNCTIONING NORMALLY. THE PT WENT INTO CARDIAC ARREST DUE TO A PREEXISTING MEDICAL CONDITION. THE VENTILATOR WAS REMOVED FROM THE PT BUT KEPT RUNNING WITH A TEST LUNG TO BE READY TO BE RE-ATTACHED TO THE PT. AFTER THE PT HAD BEEN DEFIBRILLATED AND WAS READY TO BE RE-ATTACHED TO THE VENTILATOR, THE VENTILATOR DISPLAYED WHITE SCREEN AND DEVICE ALERT ALARM WENT OFF. WHEN THIS ISSUE OCCURRED, THE PT WAS STILL OFF THE VENTILATOR. HOWEVER, DUE TO THIS ISSUE THE PT WAS AMBU BAGGED AND ANOTHER VENTILATOR WAS ATTACHED. NO PERMANENT INJURY WAS REPORTED FOR 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 54 YR Required Intervention DEFIBRILLATOR