BEUDAMED
    FDA Adverse Event Other Summary report: N

    E360 VENTILATOR

    MDR report key: 1889058 · Received October 26, 2010

    Report

    Report Number
    2023050-2010-00047
    Event Type
    Other
    Date Received
    October 26, 2010
    Date of Event
    September 29, 2010
    Report Date
    October 4, 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
    MY
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, THE VENTILATOR STOPPED WORKING WHILE IN USE ON A PT. THE PT WAS AMBU BAGGED AND THEN SWITCHED TO ANOTHER VENTILATOR. THE PT WAS NOT VENTILATOR DEPENDENT AND WHEN THE INCIDENT OCCURRED, HE/SHE WAS WEANING FROM THE VENTILATOR. NOW, THE PT WAS DISCHARGED FROM THE HOSP WITHOUT FURTHER ISSUES REPORTED. PLEASE NOTE THAT THERE WAS NO SERIOUS 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