BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GE HEALTHCARE AESTIVA ANESTHESIA MACHINE

    MDR report key: 14188063 · Received April 21, 2022

    Report

    Report Number
    MW5109273
    Event Type
    Injury
    Date Received
    April 21, 2022
    Date of Event
    December 22, 2021
    Report Date
    April 20, 2022
    Manufacturer
    GE HEALTHCARE FINLAND OY
    Product Code
    BSZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    FOLLOWING INTUBATION AND PRIOR TO START OF SURGERY IN THE EP LAB, THE GE AESTIVA ANESTHESIA MACHINE WAS UNABLE TO MANUALLY VENTILATE PATIENT IN THE BAG MODE. BAG WAS DISTENDED BUT NO CHEST RISE OBSERVED WHEN SQUEEZED. PT SPO2 VALUES DECREASED FOR PERIOD OF 4 MINUTES, UNTIL MACHINE WAS ABLE TO VENTILATE IN MECHANICAL VENTILATION MODE. THE INTERVENTION REQUIRED TO PREVENT PERMANENT IMPAIRMENT/DAMAGE AT THIS POINT IS THAT AN AMBU-BAG HAD TO BE USED TO DELIVER OXYGEN TO THE PT. NEXT, THE MACHINE WAS RECONNECTED TO THE PT, AND SUCCESSFULLY VENTILATED THE PT. IN MECHANICAL VENTILATION MODE. THE OTHER SERIOUS OR IMPORTANT MEDICAL EVENT WAS THAT THE PROCEDURE WAS CANCELLED AS A RESULT OF THE DESATURATION EVENT. PT WAS NOT FOUND TO HAVE SUSTAINED ANY NEUROLOGICAL DAMAGE AS A RESULT OF EVENT, WAS DISCHARGED FROM HOSPITAL, AND PROCEDURE WAS SUCCESSFULLY PERFORMED 10 DAYS LATER. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    970284 GE HEALTHCARE AESTIVA ANESTHESIA MACHINE GAS-MACHINE, ANESTHESIA BSZ GE HEALTHCARE FINLAND OY AESTIVA/5 MRI

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other| R