BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVANCE CS2

    MDR report key: 11020626 · Received December 16, 2020

    Report

    Report Number
    2112667-2020-03498
    Event Type
    Malfunction
    Date Received
    December 16, 2020
    Date of Event
    November 20, 2020
    Report Date
    December 16, 2020
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    BSZ
    PMA / PMN Number
    K172045
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FAILURE IN THIS CASE WAS DUE TO ANOTHER MANUFACTURER'S PRODUCT, THE INTERSURGICAL PATIENT CIRCUIT/BREATHING SYSTEM, PART 2151000. THE PRODUCT IS IDENTIFIED AS AN ORIGINAL EQUIPMENT MANUFACTURER COMPONENT THAT IS IMPORTED BY GE HEALTHCARE. NO REPORT OF PATIENT INVOLVEMENT. THE INITIAL REPORTER IS LOCATED OUTSIDE THE U.S., AND THEREFORE THIS INFORMATION IS NOT PROVIDED DUE TO COUNTRY PRIVACY LAWS.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED A LEAK GREATER THAN 4.5 LPM RESULTING IN THE LOSS OF ALL VENTILATION MODES. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1484128 AVANCE CS2 ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1