BEUDAMED
    FDA Adverse Event Death Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 15529721 · Received October 3, 2022

    Report

    Report Number
    3001421318-2022-00016
    Event Type
    Death
    Date Received
    October 3, 2022
    Date of Event
    August 31, 2022
    Report Date
    September 29, 2022
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    QA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE HAMILTON-S1 IS NOT DISTRIBUTED IN THE UNITED STATES; HOWEVER, HAMILTON MEDICAL AG CONSIDERS THE HAMILTON-S1 SIMILAR TO THE HAMILTON (K193228) IN THAT THE TWO VENTILATORS HAVE BASIC DESIGN AND PERFORMANCE CHARACTERISTICS RELATED TO DEVICE SAFETY AND EFFECTIVENESS, HAVE THE SAME INTENDED USE AND FUNCTION, AND HAVE THE SAME DEVICE CLASSIFICATION AND PRODUCT CODE UNDER 21 CFR 868.5895. ADDITIONAL INFORMATION WAS REQUESTED ABOUT THE CASE. BASED ON THE INFORMATION RECEIVED FROM THE STAFF ATTENDING AT THE TIME OF THE INCIDENT AND THE PATIENT RECORD, IT WAS CONFIRMED THAT THE PATIENT DEATH WAS DUE TO A HEART ATTACK AND NOT CAUSED BY THE VENTILATOR GOING INTO AMBIENT STATE. THE HOSPITAL IS NOT ASKING FOR FURTHER INVESTIGATION OF THIS CASE. NEVERTHELESS, THE LOG FILES OF THE DEVICE WERE RECEIVED AND ANALYZED. ACCORDING TO THE LOG FILES, THE FIRST EVENT OCCURRED ON (B)(6) 2022 (STANDBY ON). THE VENTILATOR SHOWED TECHNICAL FAULT (TF) 5509, WHICH SOUNDS HIGH-PRIORITY ALARM THAT CANNOT BE SILENCED BY THE USER AND DISPLAYS THE TECHNICAL FAULT NUMBER ON THE SCREEN, AND WENT IMMEDIATELY INTO AMBIENT STATE. AMBIENT STATE IS A STATE THAT THE HAMILTON-S1 VENTILATOR USES WHEN IT CANNOT FUNCTION NORMALLY BECAUSE OF AN INTERNAL OR EXTERNAL FAULT. IN THIS STATE, THE INSPIRATORY VALVE CLOSES, THE EXPIRATORY VALVE OPENS, AND THE MIXER VALVES SHUT OFF THE AIR AND OXYGEN SUPPLY TO THE TANK. THE PATIENT IS NOT ACTIVELY VENTILATED IN ANY WAY, BUT IS ALLOWED TO INHALE THROUGH THE AMBIENT VALVE IF ABLE TO DO SO. ACCORDING TO THE LOG FILES ON 05/08/2022, THE DEVICE SHOWED TF 5509 AND 9907, AND WENT INTO AMBIENT STATE DURING VENTILATION. ON 08/31/2022 LOG FILES RECORDED SEVERAL EVENTS ONE AFTER ANOTHER, INCLUDING A TF 5509 AND 9907, AND IMMEDIATELY WENT INTO AMBIENT STATE, AFTER EACH EVENT. EVENTS OCCURRED AT 02:46 AM, 02:49 AM, 07:55 AM, 08:21AM, 08:24 AM RESPECTIVELY. DURING ALL THE EVENTS HIGH-PRIORITY ALARM TRIGGERED AND THE SCREEN SHOWED THE TF NUMBERS. ACCORDING TO THE SERVICE MANUAL, ONE MUST DO THE FOLLOWING WHEN A SPECIFIC TF OCCURS: TF 5509: PERFORM INSPIRATORY VALVE CHECKS; REPLACE INSPIRATORY VALVE; CHECK THE EVENT LOG. TF 9907: PROVIDE ALTERNATIVE VENTILATION. CHECK THE EVENT LOG. TF 5509 INDICATES THAT THE SERVO (INSPIRATORY) VALVE IS NOT FUNCTIONING CORRECTLY. THE VALVE SHOULD HAVE BEEN REPLACED AFTER THE FIRST EVENT WHICH OCCURRED IN MAY. BASED ON OUR INVESTIGATION OF THE LOG FILES AND INFORMATION RECEIVED FROM DISTRIBUTOR, IT SEEMS AS IF ALTERNATIVE VENTILATION WAS NOT PROVIDED TO THE PATIENT AND THE DEVICE WAS KEPT IN USE (WITHOUT REPLACING THE VALVE) DESPITE SEVERAL EVENTS INCLUDING ALARMS AND THE AMBIENT STATES. HAMILTON MEDICAL AG WAS INFORMED ONLY ABOUT THE INCIDENT THAT OCCURRED ON (B)(6) 2022 BY THE HOSPITAL. THIS FILE REPORTS THE EVENT STATED IN HAMILTON MEDICAL AG CASE NUMBER (B)(4).

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION FROM THE DISTRIBUTOR: "WE GOT A CASE OF HAMILTON S1 DEVICE SHUT DOWN DURING VENTILATION. UNFORTUNATELY THE PATIENT HAS PASSED AWAY RESULTING THE SHUTDOWN. A FULL INVESTIGATION IS REQUIRED TO WHY THE ERROR HAPPENED AND WHAT IS THE CAUSES OF THE SHUTDOWN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2076363 HAMILTON MEDICAL AG HAMILTON-S1 CBK HAMILTON MEDICAL AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death