BEUDAMED
    FDA Adverse Event Other Summary report: N

    E360 VENTILATOR

    MDR report key: 2091107 · Received May 6, 2011

    Report

    Report Number
    2023050-2011-00017
    Event Type
    Other
    Date Received
    May 6, 2011
    Date of Event
    March 23, 2011
    Report Date
    April 6, 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
    IN
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    REPORTEDLY, THE VENTILATOR GAVE AN "AIR SERVO VALVE LEAK" ALARM DURING USE ON A PT. IT WAS ALSO REPORTED THAT MEDICAL INTERVENTION WAS TAKEN TO THE PT. NO ADD'L PT INFO WAS PROVIDED. 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