BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVANCE CS2

    MDR report key: 7635370 · Received June 25, 2018

    Report

    Report Number
    2112667-2018-01278
    Event Type
    Malfunction
    Date Received
    June 25, 2018
    Date of Event
    May 30, 2018
    Report Date
    June 25, 2018
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    BSZ
    PMA / PMN Number
    K123125
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    NO REPORT OF PATIENT INVOLVEMENT. (B)(4). GE HEALTHCARE RECOMMENDED TO CHECK/REPLACE THE DRIVE GAS CHECK VALVE.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT, DURING THE PREOPERATIVE CHECKOUT, THE UNIT HAD A FAILURE AFFECTING MECHANICAL VENTILATION. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477750 AVANCE CS2 ANESTHESIA MACHINE BSZ DATEX-OHMEDA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1