BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E360 VENTILATOR

    MDR report key: 2820507 · Received November 2, 2012

    Report

    Report Number
    2023050-2012-00239
    Event Type
    Malfunction
    Date Received
    November 2, 2012
    Date of Event
    October 10, 2010
    Report Date
    October 12, 2012
    Manufacturer
    NEWPORT MEDICLA INSTRUMENT
    Product Code
    CBK
    PMA / PMN Number
    K053502
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, DURING TESTING, THERE WAS A "BAD O2 SENSOR" AND "HIGH FIO2" ALARM. REPLACING THE OXYGEN SENSOR RESOLVED 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