BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E500 VENTILATOR SYSTEM

    MDR report key: 2860071 · Received November 21, 2012

    Report

    Report Number
    2023050-2012-00284
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 20, 2012
    Report Date
    November 2, 2012
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K061094
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, DURING TESTING, AN "O2 SENSOR BAD" ALARM OCCURRED WHICH COULD NOT BE RESOLVED BY CALIBRATION. REPLACING THE SENSOR RESOLVED THIS ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 E500 VENTILATOR SYSTEM CBK NEWPORT MEDICAL INSTRUMENTS, INC. E500

    Patients

    Seq Age Sex Outcome Treatment
    1