BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AESTIVA MRI

    MDR report key: 14112632 · Received April 14, 2022

    Report

    Report Number
    2112667-2022-00867
    Event Type
    Injury
    Date Received
    April 14, 2022
    Date of Event
    March 16, 2022
    Report Date
    June 3, 2022
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    BSZ
    PMA / PMN Number
    K172045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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. INFORMATION NOT PROVIDED. LEGAL MANUFACTURER: (B)(4). DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 0

    THE GE FIELD ENGINEER INSPECTED THE AESTIVA MRI, AND NO ISSUES WERE IDENTIFIED. THE AESTIVA MRI DELIVERED THE SET PRESSURES AFTER SWITCHING VENTILATION MODES. THIS INDICATES THAT A PATIENT CIRCUIT LEAK LIKELY CONTRIBUTED TO THE LOSS OF VENTILATION AND THAT THE LEAK WAS RESOLVED WHEN MECHANICAL VENTILATION WAS RESUMED FROM THE AESTIVA MRI, AND/OR THERE WAS AN ISSUE VENTILATING THE PATIENT THAT WAS RESOLVED BY THE ASPIRATION MANEUVER. THE ROOT CAUSE OF THE LOSS OF VENTILATION IS UNDETERMINED; THERE IS NO EVIDENCE OF ANY ELECTRICAL OR MECHANICAL ERRORS THAT CONTRIBUTED TO THE LOSS OF VENTILATION IN VOLUME-CONTROLLED MECHANICAL VENTILATION.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED A PATIENT WAS CONNECTED TO AN AESTIVA MRI DURING A MAGNETIC RESONANCE EXAM WHEN THE PATIENT DESATURATED FOLLOWED, REPORTEDLY, BY A LOWER HEART RATE. THE PATIENT WAS SWITCHED TO MANUAL VENTILATION USING AN AMBU BAG. CPR WAS PERFORMED UNTIL THE PATIENT WAS STABILIZED AND WAS UNDER OBSERVATION IN THE HOSPITALS ICU. THE PATIENT'S CURRENT CLINICAL CONDITION WAS NOT REPORTED. 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
    1639389 AESTIVA MRI ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other