BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E360 VENTILATOR

    MDR report key: 2033316 · Received March 21, 2011

    Report

    Report Number
    2023050-2011-00010
    Event Type
    Malfunction
    Date Received
    March 21, 2011
    Date of Event
    February 23, 2011
    Report Date
    February 24, 2011
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K053502
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    REPORTEDLY, DURING IN USE ON A PT IN ICU, A HOSPITAL STAFF NOTICED THAT THE VENTILATOR ONLY GAVE A VISUAL ALARM BUT NO AUDIBLE ALARM. THE PT WAS SWITCHED TO ANOTHER VENTILATOR. PLEASE NOTE THAT THE VENTILATOR WAS GIVING GAS DELIVERY NORMALLY DESPITE THE AUDIBLE ALARM ISSUE. THE VENTILATOR WAS CHECKED ITS ALARM CONDITION BEFORE USE ON A PT AND NO FAILURE WAS DETECTED. PLEASE ALSO NOTE THAT THERE WAS NO SERIOUS INJURY IN THIS EVENT.

    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