BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARESTATION 620

    MDR report key: 7292152 · Received February 23, 2018

    Report

    Report Number
    2112667-2018-00407
    Event Type
    Death
    Date Received
    February 23, 2018
    Date of Event
    January 26, 2018
    Report Date
    March 12, 2018
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    BSZ
    PMA / PMN Number
    K151570
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE PRODUCT ENGINEERING PERFORMED AN INVESTIGATION OF THIS EVENT. THE CUSTOMER MEDICAL STAFF INITIALLY REPORTED THAT THE GE HEALTHCARE ANESTHESIA MACHINE STOPPED VENTILATING PROPERLY IN VENT MODE. THE INVESTIGATION REVEALED SIGNED DOCUMENTS FROM THE CUSTOMER MEDICAL STAFF, ENGINEERING REVIEW OF THE DEVICE LOGS, AND INSPECTION BY THE GE HEALTHCARE FIELD ENGINEER CONFIRMING THAT THERE WAS NO MALFUNCTION AND THE DEVICE WAS WORKING CORRECTLY. THE PATIENT IN THIS CASE WAS (B)(6) YEARS OLD, WEIGHED (B)(6), AND PRESENTED IN CRITICAL CONDITION FOR AN EMERGENCY CRANIOTOMY. THE MEDICAL STAFF ATTRIBUTED THE PATIENT DEATH TO THE PATIENT'S CRITICAL CONDITION. BASED ON THIS INFORMATION, THE INVESTIGATION DETERMINED THAT THE GE HEALTHCARE ANESTHESIA MACHINE DID NOT MALFUNCTION AND DID NOT CAUSE OR CONTRIBUTE TO THE DEATH OF THE PATIENT. THEREFORE, THIS EVENT IS NOT REPORTABLE.

    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. UNIQUE DEVICE IDENTIFIER - (B)(4). DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT THE MACHINE STOPPED VENTILATING PROPERLY IN VENT MODE DURING A PROCEDURE. THE PATIENT DIED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136977 CARESTATION 620 ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death