BEUDAMED
    FDA Adverse Event Death Summary report: N

    AESPIRE 7900

    MDR report key: 8582628 · Received May 6, 2019

    Report

    Report Number
    2112667-2019-00184
    Event Type
    Death
    Date Received
    May 6, 2019
    Date of Event
    March 24, 2019
    Report Date
    June 12, 2019
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    BSZ
    PMA / PMN Number
    K050626
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER THE REPORTED EVENT, A GE HEALTHCARE SERVICE REPRESENTATIVE PERFORMED A CHECKOUT OF THE SYSTEM BUT DID NOT FIND ANY ISSUE WITH THE SYSTEM. THE SYSTEM PERFORMED AS EXPECTED AND WAS RETURNED TO SERVICE. ALSO, GE HEALTHCARE ENGINEERING PERFORMED AN INVESTIGATION OF THE REPORTED EVENT. THE CUSTOMER REPORTED THAT THE SYSTEM DID NOT MALFUNCTION DURING THE CASE, BUT THAT PAST CO2 READING ERRORS (DESCRIBED AS "UNORGANIZED CO2 WAVE FORM OR FALSE LOW READING") ON THE GAS MODULE LED THE TEAM TO FAIL TO RESPOND APPROPRIATELY TO THE "LINE OCCLUDED" MESSAGE ON THE GAS MODULE IN A TIMELY MANNER, LEADING TO AN ANOXIC BRAIN INJURY. THE AESPIRE 7900 IS SEPARATE FROM THE GAS MODULE, BUT READINGS FROM THE GAS MODULE ARE USED TO INFORM USERS OF SETTINGS AND SETUP CHANGES THAT SHOULD BE MADE ON THE AESPIRE 7900. REVIEW OF COMPLAINT DATA INDICATES NO MALFUNCTION OF THE AESPIRE 7900 SYSTEM THAT COULD CAUSE OR CONTRIBUTE TO A PATIENT'S DEATH. THE ROOT CAUSE IS UNDETERMINED.

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED. PATIENT WEIGHT INFORMATION UNAVAILABLE. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED AN ALLEGED FAILURE OF THE SYSTEM RESULTING IN EXCESS CO2, LEADING TO BRAIN INJURY DURING PROCEDURE AND EVENTUAL PATIENT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375577 AESPIRE 7900 ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA, INC. 1009-9012-000

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death