BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E360 VENTILATOR

    MDR report key: 3040314 · Received April 3, 2013

    Report

    Report Number
    2023050-2013-00261
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    February 28, 2013
    Report Date
    March 11, 2013
    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, THE VENTILATOR DISPLAYED A WHITE SCREEN AND COULD NOT BE OPERATED. UPON REPLACING THE SINGLE BOARD COMPUTER, THIS ISSUE WAS RESOLVED. THERE WAS NO PT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135930 E360 VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS, INC. E360

    Patients

    Seq Age Sex Outcome Treatment
    1