BEUDAMED
    FDA Adverse Event Death Summary report: N

    AISYS

    MDR report key: 8598793 · Received May 10, 2019

    Report

    Report Number
    2112667-2019-00185
    Event Type
    Death
    Date Received
    May 10, 2019
    Date of Event
    April 15, 2019
    Report Date
    June 26, 2019
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    BSZ
    PMA / PMN Number
    K042154
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER THE REPORTED EVENT, THE CUSTOMER REQUESTED A FUNCTIONAL CHECK OF THE MACHINE BEFORE PUTTING IT BACK IN USE. A GE HEALTHCARE SERVICE REPRESENTATIVE PERFORMED A CHECKOUT OF THE SYSTEM BUT DID NOT FIND ANY ISSUES WITH THE SYSTEM. GE HEALTHCARE PRODUCT ENGINEERING PERFORMED AN INVESTIGATION OF THIS EVENT. A REVIEW OF THE SYSTEM LOGS CONFIRMED NO EVIDENCE OF A SYSTEM FAULT OR GAS DELIVERY MALFUNCTION OF THE AISYS THAT COULD CAUSE OR CONTRIBUTE TO A PATIENT DEATH. THE ROOT CAUSE OF THE REPORTED EVENT IS UNDETERMINED. ADDITIONAL INFORMATION WAS REQUESTED REGARDING PRE-PROCEDURE PATIENT CONDITION OR CO-MORBIDITIES BUT WAS NOT PROVIDED.

    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 INFORMATION COULD NOT BE OBTAINED DUE TO COUNTRY PRIVACY LAWS. THE INITIAL REPORTER IS LOCATED OUTSIDE THE U.S., AND THEREFORE THIS INFORMATION IS NOT PROVIDED DUE TO COUNTRY PRIVACY LAWS. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    THE HOSPITAL ASKED FOR A FUNCTIONAL CHECK OF THE SYSTEM AFTER THEY REPORTED DIFFICULTY VENTILATING A PATIENT. THE PATIENT DIED DURING THE SURGERY PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391844 AISYS ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death