BEUDAMED
    FDA Adverse Event Death Summary report: N

    AISYS

    MDR report key: 8560166 · Received April 29, 2019

    Report

    Report Number
    2112667-2019-00182
    Event Type
    Death
    Date Received
    April 29, 2019
    Date of Event
    March 29, 2019
    Report Date
    June 6, 2019
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    BSZ
    PMA / PMN Number
    K042154
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    GE HEALTHCARE PRODUCT ENGINEERING PERFORMED AN INVESTIGATION OF THIS EVENT. A GE HEALTHCARE SERVICE REPRESENTATIVE RETRIEVED THE LOGS FOR THE TIME THIS EVENT OCCURRED (B)(6) 2019 AT 12:00:00), AS REQUESTED BY THE CUSTOMER FOR AN INTERNAL INVESTIGATION. THE LOGS SHOW THE FINAL DAY OF USE BEFORE THE LOGS WERE OBTAINED WAS B)(6) 2019. REVIEW OF THE DEVICE LOGS FOR THE SECOND AND FINAL CASE ON 29-MAR-2019 DID NOT REVEAL ANY RESETS OR STOPPAGES OF THE DEVICE. AT 1:15 PM THE DEVICE REPORTED A POSITIVE END EXPIRATORY PRESSURE (PEEP) PRESSURE CONTROL VENTILATION (PCV) NOT AVAILABLE ALARM WHICH CLEARED AFTER THREE MINUTES. THE DEVICE WAS IN VOLUME CONTROL VENTILATION (VCV) AT THE TIME OF THE ALARM, SO VENTILATION WAS NOT LOST. THE ALARM ACTIVATION AND DEACTIVATION IS HIGHLIGHTED IN THE LOGS. THE USER CONTINUED TO VENTILATE WITH THE DEVICE FOR AN HOUR UNTIL THE END OF THE CASE. PARAMETER ALARMS WERE PRESENT THROUGHOUT THE CASE BUT THERE IS NO INDICATION OF A DEVICE MALFUNCTION CAUSING OR CONTRIBUTING TO THEIR PRESENCE. THE CUSTOMER HAS MADE NO ALLEGATION OF FAILURE AGAINST THE SYSTEM. A ROOT CAUSE CANNOT BE ESTABLISHED AS THERE WAS NO ALLEGATION OF FAULT AGAINST THE DEVICE. BECAUSE THERE IS NO ALLEGATION OF FAILURE AND THERE IS NO EVIDENCE OF SYSTEM MALFUNCTION, IT IS DETERMINED THAT THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT DEMISE.

    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 ID AND PATIENT WEIGHT UNAVAILABLE. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED A PATIENT DEATH DURING A COMPLEX WOUND PROCEDURE BEING PERFORMED ON A (B)(6) YEAR OLD OBESE FEMALE PARAPLEGIC PATIENT WITH MULTIPLE COMORBIDITIES IN THE PRONE POSITION. THERE IS NO ALLEGATION OF ANESTHESIA MACHINE MALFUNCTION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353836 AISYS ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA, INC. 1011-9000-000

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Death