BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E360 VENTILATOR

    MDR report key: 2860088 · Received November 21, 2012

    Report

    Report Number
    2023050-2012-00289
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 13, 2012
    Report Date
    November 1, 2012
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K053502
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, DURING TESTING, THERE WAS AN "O2 SENSOR ERROR" ALARM THAT OCCURRED AFTER OXYGEN SENSOR CALIBRATION. THE VENTILATOR WAS RE-STARTED BUT THE ISSUE WAS NOT RESOLVED. UPON REPLACING THE OXYGEN SENSOR, THIS ISSUE WAS RESOLVED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1