BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E360 VENTILATOR

    MDR report key: 4092621 · Received August 19, 2014

    Report

    Report Number
    2023050-2014-00356
    Event Type
    Malfunction
    Date Received
    August 19, 2014
    Date of Event
    August 7, 2014
    Report Date
    August 7, 2014
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K053502
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE OXYGEN SENSOR WAS REPLACED TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFORMATION STATING THAT THE OXYGEN SENSOR FAILED CALIBRATION ON THE E360 VENTILATOR. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496939 E360 VENTILATOR CONTINUOUS VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS, INC. E360

    Patients

    Seq Age Sex Outcome Treatment
    1