BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E360 VENTILLATOR

    MDR report key: 2894450 · Received December 27, 2012

    Report

    Report Number
    2023050-2012-00371
    Event Type
    Malfunction
    Date Received
    December 27, 2012
    Date of Event
    November 28, 2012
    Report Date
    December 11, 2012
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K053502
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, DURING TESTING, THERE WAS A BLACK SCREEN. AS REPORTED BY THE DISTRIBUTOR, UPON REPLACING THE EXTERNAL BACKLIGHT INVERTER BOARD, THE ISSUE WAS RESOLVED. THERE WAS NO PT INVOLVEMENT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1