BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVANCE CS2

    MDR report key: 14592807 · Received June 3, 2022

    Report

    Report Number
    2112667-2022-01388
    Event Type
    Injury
    Date Received
    June 3, 2022
    Date of Event
    April 28, 2022
    Report Date
    October 21, 2022
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    BSZ
    PMA / PMN Number
    K172045
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. NO PATIENT INFORMATION IS AVAILABLE. LEGAL MANUFACTURER: (B)(4). DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 0

    THE ROOT CAUSE IS UNDETERMINED, BECAUSE THERE IS NO EVIDENCE OF DEVICE MALFUNCTION, AND IT IS UNKNOWN WHETHER THE DEVICE CONTRIBUTED TO THE PATIENTS DROP IN BLOOD PRESSURE. THE DEVICE LOGS SHOW THAT THE SYSTEM CHECKOUT WAS BYPASSED PRIOR TO THE CASE, AND AFTER THE REPORTED INCIDENT, THE CASE CONTINUED FOR 9 HOURS. THE LOGS ALSO SHOW THAT THE BELLOWS COLLAPSED AT 6:00AM, 2 MINUTES AFTER THE REPORTED TIME OF THE OCCURRENCE. FURTHER, THE LOGS REVEAL NO ALARMS/ERRORS 10 MINUTES PRIOR TO THE BLOOD PRESSURE DROP. DUE TO THE MACHINE FUNCTIONING NORMALLY FOR THE REST OF THE CASE WITHOUT ANY MAINTENANCE NOTED IN THE COMPLAINT OR SEEN IN THE DEVICE LOGS, THE MOST LIKELY SCENARIO IS THAT THERE WAS A LEAK OR DISCONNECT IN THE PATIENT BREATHING CIRCUIT WHICH CAUSED THE BELLOWS TO COLLAPSE. THE PATIENTS BLOOD PRESSURE LIKELY DROPPED DUE TO THEIR POOR CONDITION DURING SURGERY, THE SEDATION DRUGS GIVEN, AND/OR A LEAK IN THE BREATHING SYSTEM.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED A PATIENT CONNECTED TO AN AVANCE CS2 HAD A SUDDEN DROP IN BLOOD PRESSURE AT 5:58. RESUSCITATION MEASURES WERE GIVEN. AT 6:00, IT WAS DETERMINED THAT THE BELLOWS OF THE AVANCE CS2 WERE NOT BEING SUPPLIED WITH AIR. THE AVANCE CS2 WAS RESTARTED, NORMAL VENTILATION RESUMED, AND PATIENT RECOVERED. 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
    1832940 AVANCE CS2 ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention