BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E360 VENTILATOR

    MDR report key: 2820512 · Received November 2, 2012

    Report

    Report Number
    2023050-2012-00243
    Event Type
    Malfunction
    Date Received
    November 2, 2012
    Date of Event
    September 25, 2012
    Report Date
    October 17, 2012
    Manufacturer
    NEWPORT MEDICLA INSTRUMENT
    Product Code
    CBK
    PMA / PMN Number
    K053502
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, DURING TESTING, O2 SENSOR ERROR OCCURRED WHICH COULD NOT BE SOLVED THIS ISSUE. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 E360 VENTILATOR CBK NEWPORT MEDICLA INSTRUMENT E360

    Patients

    Seq Age Sex Outcome Treatment
    1