BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E360 VENTILATOR, JAPANESE EXPANDED

    MDR report key: 2903010 · Received December 21, 2012

    Report

    Report Number
    2023050-2012-00356
    Event Type
    Injury
    Date Received
    December 21, 2012
    Report Date
    November 29, 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

    ALTHOUGH REQUESTED, NO PT INFO WAS PROVIDED.

    Description of Event or Problem · 1

    DURING PT USE, AN 'O2 LOSS' ALARM OCCURRED. THE PT WAS AMBU BAGGED AND SWITCHED TO ANOTHER VENTILATOR. LATER, DISTRIBUTOR'S SERVICE STAFF FOUND THAT THE LUER CONNECTOR BETWEEN THE SERVO VALVE AND ANALOG BOARD AT O2 SIDE CAME OFF. TIGHTENING ALL CONNECTOR BY THE DISTRIBUTOR'S SERVICE STAFF AT THE HOSPITAL RESOLVED THIS ISSUE. NO PERMANENT INJURY WAS REPORTED IN THIS CASE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention