BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E360 VENTILATOR

    MDR report key: 3954632 · Received July 11, 2014

    Report

    Report Number
    2023050-2014-00291
    Event Type
    Injury
    Date Received
    July 11, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 20, 2014
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K053502
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO AVAILABLE INFO REGARDING THE VENTILATOR BEING ALREADY REPAIRED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRINTED CIRCUIT BOARD (PCB) WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED AND NO ANOMALIES OBSERVED. FUNCTIONALITY TESTS WERE PERFORMED, AND THE CUSTOMER REPORTED COMPLAINT COULD NOT BE DUPLICATED. IT WAS INSTALLED INTO A VENTILATOR TEST UNIT, POWERED UP, AND STARTED VENTILATING. THE VENTILATOR WAS ALLOWED TO VENTILATE FOR OVER 48 HOURS, AND NO ALARMS OR ERRORS WERE GENERATED. THE UNIT PASSED ALL TESTS AND CALIBRATIONS, AND IT WAS OPERATING WITHIN THE MANUFACTURING SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER IN THE USA THAT, DURING PT USE, THE E360 VENTILATOR GENERATED A CONTINUOUS "CON PROC FAILED" ALARM. THE PT WAS MANUALLY VENTILATED AND TRANSFERRED TO ANOTHER VENTILATOR. THERE WAS NO REPORTED PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406960 E360 VENTILATOR CONTINUOUS VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS, INC. E360

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention