BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E360 VENTILATOR

    MDR report key: 1892510 · Received November 1, 2010

    Report

    Report Number
    2023050-2010-00048
    Event Type
    Malfunction
    Date Received
    November 1, 2010
    Report Date
    November 1, 2010
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K053502
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    REPORTEDLY, THERE WAS SMOKE COMING FROM EITHER THE VENTILATOR OR THE EXTERNAL SCREEN ALONG WITH SOME SMELL DURING USE ON A PT. THEN, THE GUI AND THE EXTERNAL SCREEN TURNED BLACK. THE VENTILATOR WAS SWITCHED TO ANOTHER ONE WITHOUT FURTHER ISSUES. THERE WAS NO PT INJURY IN THIS CASE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK