BEUDAMED
    FDA Adverse Event Other Summary report: N

    E360 VENTILATOR

    MDR report key: 1696546 · Received May 18, 2010

    Report

    Report Number
    2023050-2010-00017
    Event Type
    Other
    Date Received
    May 18, 2010
    Date of Event
    January 1, 2009
    Report Date
    April 20, 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
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT DATE OF EVENT IS UNK. IT WAS SOMETIME IN 2009.

    Description of Event or Problem · 1

    REPORTEDLY, THE RESPIRATORY THERAPIST FOUND THAT THE VENTILATOR WAS UNEXPECTEDLY SHUTDOWN ON A PT. THE VENTILATOR ALARMED CONSTANTLY AND IT DID NOT POWER BACK ON AGAIN. THE VENTILATOR WAS RUNNING ON AC POWER AT THE TIME. THE PT WAS AMBU BAGGED AND THEN SWITCHED TO ANOTHER VENTILATOR. 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