BEUDAMED
    FDA Adverse Event Death Summary report: N

    AISYS CS2

    MDR report key: 13252549 · Received January 13, 2022

    Report

    Report Number
    2112667-2022-00091
    Event Type
    Death
    Date Received
    January 13, 2022
    Date of Event
    December 8, 2021
    Report Date
    May 3, 2022
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    BSZ
    PMA / PMN Number
    K172045
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED. NO PATIENT INFORMATION PROVIDED TO DATE. DATE OF DEATH: NOT PROVIDED. UNIQUE IDENTIFIER: (B)(4). LEGAL MANUFACTURER: (B)(4).

    Additional Manufacturer Narrative · 0

    GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED. NO PATIENT INFORMATION PROVIDED TO DATE. DATE OF DEATH: NOT PROVIDED. UNIQUE IDENTIFIER: (B)(4). LEGAL MANUFACTURER: (B)(4).

    Additional Manufacturer Narrative · 0

    THE DEVICE LOGS DO NOT INDICATE ANY MECHANICAL OR ELECTRICAL ERRORS, AND INSPECTION OF THE DEVICE BY HOSPITAL ENGINEERING AND GE FIELD SERVICE DID NOT IDENTIFY ANY SOURCE OF MALFUNCTION. SINCE THE CASE STARTED AT 11:14 AM ON 08DEC2021, THE DEVICE ALARMS WERE APPROPRIATE AND CONSISTENT WITH A DIFFICULT AIRWAY. INABILITY TO VENTILATE DESPITE ATTEMPTS TO MECHANICALLY VENTILATE AND USE A MAPLESON/AMBU-BAG ALSO ARE INDICATIVE OF A DIFFICULT AIRWAY. THE CUSTOMER STATES THAT THE UNIT WAS USED ON CASES BOTH BEFORE AND AFTER THE INCIDENT WITHOUT ISSUE. FROM THE DESCRIPTION BY THE CUSTOMER REGARDING THE BEGINNING OF THE CASE AND INTUBATION, THERE WERE LIKELY ISSUES WITH THE PATIENT RECEIVING THE VENTILATION. THEREFORE, THE ROOT CAUSE OF THE PATIENT DEATH IS UNDETERMINED AND THERE IS NO EVIDENCE OF DEVICE MALFUNCTION.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED A PATIENT DEATH DURING USE OF THE AISYS CS2. IT WAS REPORTED THAT ANESTHESIA PROVIDERS WERE UNABLE TO VENTILATE THE PATIENT AFTER INDUCTION OF ANESTHESIA AND INTUBATION. GE HEALTHCARE WILL SUBMIT A FOLLOW-UP REPORT WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED A PATIENT DEATH DURING USE OF THE AISYS CS2. IT WAS REPORTED THAT ANESTHESIA PROVIDERS WERE UNABLE TO VENTILATE THE PATIENT AFTER INDUCTION OF ANESTHESIA AND INTUBATION. GE HEALTHCARE WILL SUBMIT A FOLLOW-UP REPORT WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637478 AISYS CS2 ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA, INC. 1011-9050-000

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death