BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AISYS CS2

    MDR report key: 12001206 · Received June 15, 2021

    Report

    Report Number
    2112667-2021-01519
    Event Type
    Malfunction
    Date Received
    June 15, 2021
    Date of Event
    May 27, 2021
    Report Date
    June 15, 2021
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    BSZ
    PMA / PMN Number
    K132530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    UNIQUE IDENTIFIER: (B)(4). PATIENT INFORMATION COULD NOT BE OBTAINED DUE TO COUNTRY PRIVACY LAWS. THE INITIAL REPORTER IS LOCATED OUTSIDE THE U.S., AND THEREFORE THIS INFORMATION IS NOT PROVIDED DUE TO COUNTRY PRIVACY LAWS. A GE HEALTHCARE SERVICE REPRESENTATIVE PERFORMED A CHECKOUT OF THE SYSTEM AND CONFIRMED THE REPORTED ISSUE. THE FLOW SENSOR WAS REPLACED TO RESOLVE THE REPORTED ISSUE. HTTP://EMDR.FDA.GOV/EMDR/FORMREDACTION/D11.JSF#.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED A FLOW SENSOR ISSUE WHERE THE DIAPHRAGM WAS STUCK OPEN. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    900525 AISYS CS2 ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1