BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E360 VENTILATOR

    MDR report key: 3871290 · Received April 15, 2014

    Report

    Report Number
    2023050-2014-00138
    Event Type
    Malfunction
    Date Received
    April 15, 2014
    Date of Event
    June 28, 2013
    Report Date
    March 16, 2014
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K053502
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFO STATING THAT DURING PT USE, THE TOUCH SCREEN DID NOT FUNCTION PROPERLY. THERE WAS NO MEDICAL INTERVENTION OR ADVERSE PT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230569 E360 VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS, INC. E360

    Patients

    Seq Age Sex Outcome Treatment
    1