BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E360 VENTILATOR

    MDR report key: 2831728 · Received November 9, 2012

    Report

    Report Number
    2023050-2012-00258
    Event Type
    Injury
    Date Received
    November 9, 2012
    Date of Event
    September 28, 2012
    Report Date
    October 21, 2012
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS
    Product Code
    CBK
    PMA / PMN Number
    K053502
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THOUGH REQUESTED, PATIENT INFORMATION WAS NOT PROVIDED.

    Description of Event or Problem · 1

    REPORTEDLY, DURING PATIENT USE, AFTER SUCTIONING THE PATIENT, THE PEAK INSPIRATORY PRESSURE (PIP) VALUE WAS FOUND TO BE LOW AND THE TIDAL VOLUME DISPLAYED WAS HIGH. THE TEST LUNG DID NOT EXPAND. THE UNIT WAS POWERED ON AND OFF AND THE UNIT WAS CHECKED FOR A LEAK. AFTER PERFORMING A CIRCUIT CHECK, THE ISSUE WAS RESOLVED. HOWEVER, THE PATIENT WAS MANUALLY VENTILATED AND TRANSFERRED TO ANOTHER VENTILATOR. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention