BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVANCE CS2

    MDR report key: 9180903 · Received October 11, 2019

    Report

    Report Number
    2112667-2019-01453
    Event Type
    Malfunction
    Date Received
    October 11, 2019
    Date of Event
    September 4, 2019
    Report Date
    October 11, 2019
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    BSZ
    PMA / PMN Number
    K123125
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    UDI: (B)(4). LEGAL MANUFACTURER: HCS MADISON (B)(4). GE HEALTHCARE TECHNICAL SUPPORT WAS UNABLE TO EVALUATE THE REPORTED EVENT. NO RESOLUTION IS AVAILABLE. NO PATIENT INFORMATION PROVIDED.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THE UNIT WAS NOT ABLE TO PERFORM FLUID SUCTIONING. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    973287 AVANCE CS2 ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1