BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E360 VENTILATOR

    MDR report key: 4221672 · Received November 3, 2014

    Report

    Report Number
    2023050-2014-00458
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    July 15, 2014
    Report Date
    October 30, 2014
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K053502
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED TO HAVE REPLACED FOUR FLOW SENSORS WITHIN 30 DAYS, AND IT HAS NOT RESOLVED THE ISSUE. AFTER REPLACING THE FORTH FLOW SENSOR, THE CABLE WITH THE EXHALATION FLOW SENSOR BOARD WAS ALSO REPLACED, AND THE UNIT WORKED NORMALLY. THE UNIT PASSED ALL TESTS AND CALIBRATIONS, AND IT WAS OBSERVED TO BE OPERATING WITHIN MANUFACTURING SPECIFICATIONS. THE DEVICE HAS BEEN RETURNED TO PATIENT USE.(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER IN (B)(6) THAT, DURING PATIENT USE, THE E360 VENTILATOR GENERATED A ¿SENSOR ERROR¿ ALERT MESSAGE, AND THE FLOW SENSOR BECAME NON-FUNCTIONAL. THE PATIENT WAS TRANSFERRED TO ANOTHER VENTILATOR. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702381 E360 VENTILATOR CONTINUOUS VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS, INC. E360

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention