BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AISYS CS2

    MDR report key: 12280043 · Received August 5, 2021

    Report

    Report Number
    2112667-2021-01824
    Event Type
    Malfunction
    Date Received
    August 5, 2021
    Date of Event
    July 7, 2021
    Report Date
    September 9, 2021
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    BSZ
    PMA / PMN Number
    K132530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    A GE HEALTHCARE SERVICE REPRESENTATIVE PERFORMED A CHECKOUT OF THE SYSTEM AND CONFIRMED THE REPORTED ISSUE. THE ELECTRONIC VAPORIZER/FRESH GAS CONTROLLER (FGC) WAS REPLACED TO RESOLVE THE ISSUE.

    Additional Manufacturer Narrative · 1

    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. UNIQUE IDENTIFIER: (B)(4). GE HEALTHCARES INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED ANESTHETIC AGENT OUTPUT IN EXCESS OF SET VALUE. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1179829 AISYS CS2 ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1