BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GE HEALTHCARE FINDLAND OY E-SCAIO ANASTHESIA GAS MODULE

    MDR report key: 19260445 · Received May 6, 2024

    Report

    Report Number
    MW5154616
    Event Type
    Injury
    Date Received
    May 6, 2024
    Date of Event
    May 2, 2024
    Report Date
    May 2, 2024
    Manufacturer
    GE HEALTHCARE / GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
    Product Code
    CCK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A GE HEALTHCARE FINLAND GAS MODULE FOR THE GE AVANCE CS2 ANESTHESIA MACHINE MALFUNCTIONED AS I WAS ABOUT TO INDUCE GENERAL ANESTHESIA. IT WAS ONLY BECAUSE I HAPPEN TO LOOK OVER AND SEE AN ERROR MESSAGE (NO ALARM) THAT I DID NOT PUSH PROPOFOL INTO THE PATIENT. THIS MALFUNCTION WOULD HAVE PREVENTED ME FROM DETECTING CARBON DIOXIDE AND ANESTHETIC GASES AND COULD HAVE PREVENTED ME FROM RAPID DETECTION OF ESOPHAGEAL INTUBATION WHICH COULD BE FATAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99510 GE HEALTHCARE FINDLAND OY E-SCAIO ANASTHESIA GAS MODULE ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE CCK GE HEALTHCARE / GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. E-SCAIO-00

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Male Required Intervention