BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVANCE CS2

    MDR report key: 6166987 · Received December 12, 2016

    Report

    Report Number
    2112667-2016-02411
    Event Type
    Malfunction
    Date Received
    December 12, 2016
    Date of Event
    November 16, 2016
    Report Date
    December 12, 2016
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    BSZ
    PMA / PMN Number
    K123125
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PK
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A GE HEALTHCARE SERVICE REPRESENTATIVE PERFORMED A CHECKOUT OF THE SYSTEM AND CONFIRMED THE REPORTED ISSUE. DURING INSPECTION OF THE EQUIPMENT, IT WAS NOTED THAT THE FLOW SENSOR DIAPHRAGM WAS STUCK TO THE TOP OF THE FLOW SENSOR HOUSING. THE FLOW SENSORS WERE REPLACED.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT, DURING A CASE, TIDAL VOLUME WAS NOTED TO BE LOWER THAN EXPECTED. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817167 AVANCE CS2 ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1