BEUDAMED
    FDA Adverse Event Death Summary report: N

    HAMILTON G5

    MDR report key: 21501960 · Received March 3, 2025

    Report

    Report Number
    3001421318-2025-00360
    Event Type
    Death
    Date Received
    March 3, 2025
    Date of Event
    January 17, 2025
    Report Date
    September 17, 2025
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002802208
    PMA / PMN Number
    K193228
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4). INVESTIGATION ONGOING.

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG REFERENCE NUMBER: (B)(4). FOLLOW-UP 1: COMPLAINT INVESTIGATION. HAMILTON MEDICAL AG RECEIVED AN EVENT INDICATING THAT THE VENTILATOR EXHIBITED AUTO-TRIGGERING BEHAVIOR WHILE IN USE ON A PATIENT. IN RESPONSE, THE PATIENT WAS IMMEDIATELY DISCONNECTED AND BAGGED TO ALLOW FURTHER INVESTIGATION. CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED; HOWEVER, THE PATIENT PASSED AWAY. ADDITIONALLY, ACCORDING TO THE COMPLAINT DESCRIPTION, AT HARM "YES" WAS SELECTED WITH THE FOLLOWING MENTION: "UNKNOWN IF HARMED BY MACHINE, PATIENT DID EXPIRE." IT WAS FURTHER NOTED THAT THE PATIENT HAD EXPERIENCED THREE CARDIAC ARRESTS IN THE EMERGENCY DEPARTMENT PRIOR TO BEING PLACED ON THE G5 VENTILATOR ON (B)(6). THE VENTILATOR¿S LOGFILES WERE RECEIVED AND REVIEWED BY THE MANUFACTURER. THE DATA REVEALED DISCONNECTION ALARM AS WELL AS THE PRESENCE OF TECHNICAL FAULT TF:2441. THE FOLLOWING RELEVANT LOG ENTRIES WERE RECORDED: (B)(6) 2025 09:35:39 HIGH PRESSURE ALARMS 5019, (B)(6) 2025 09:35:37 HIGH PRESSURE ALARMS 5019, (B)(6) 2025 09:35:37 DISCONNECTION ON VENTILATOR SIDE ALARMS 5011, (B)(6) 2025 09:35:36 HIGH PRESSURE ALARMS 5019, (B)(6) 2025 09:35:35 HIGH PRESSURE ALARMS 5019, (B)(6) 2025 09:30:09 TF : 2441 TECH FAULT 2441. FOLLOWING THE EVENT, A SERVICE TECHNICIAN INSPECTED THE VENTILATOR. ALL CALIBRATIONS WERE WITHIN SPECIFICATION, AND NO FUNCTIONAL ISSUE WAS IDENTIFIED. THE DEVICE WAS TESTED IN ACCORDANCE WITH THE MANUFACTURER¿S SERVICE MANUAL, AND ALL TESTS PASSED SUCCESSFULLY. THE VENTILATOR RAN FOR APPROXIMATELY 24 HOURS ON TEST LUNG WITHOUT ANY ISSUE. BASED ON THE AVAILABLE INFORMATION, A CAUSAL RELATIONSHIP BETWEEN THE DEVICE BEHAVIOR AND THE PATIENT¿S OUTCOME COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: QUOTATION FROM THE REPORTER: " HAMILTON G5 SN (B)(6) WAS ON A PATIENT WHO EXPIRED, UNKNOWN OF ANY PROBLEMS OR ISSUES THAT LED TO THIS. " "TECH DID INSPECT MACHINE AFTER INCIDENT AND MENTIONED THAT EXP. VALVE MAY BE STICKY. " ACCORDING TO THE INFORMATION RECEIVED IT IS UNKNOWN IF THE PATIENT WAS HARMED BY MACHINE. A MEDICAL INTERVENTION WAS NECESSARY, BUT THE SPECIFIC TYPE OF INTERVENTION REQUIRED WAS NOT SPECIFIED. MOREOVER, THE MANUFACTURER WAS INFORMED THAT THE USER REPORTED THIS EVENT TO LOCAL AUTHORITIES, ALTHOUGH NO REFERENCE NUMBER WAS PROVIDED. FURTHER INQUIRIES HAVE BEEN SENT TO THE CUSTOMER TO OBTAIN ADDITIONAL DETAILS ABOUT THE EVENT. THE CAUSALITY OF THE ADVERSE EVENT ASSOCIATED WITH THE HAMILTON-G5 HAS NOT YET BEEN DETERMINED AND IS CURRENTLY UNDER INVESTIGATION

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: THE VENTILATOR EXHIBITED AUTO-TRIGGERING BEHAVIOR WHILE IN USE ON A PATIENT. THE RESPIRATORY THERAPIST EVALUATED THE UNIT BUT FOUND NO ISSUES. THE PATIENT WAS IMMEDIATELY DISCONNECTED AND BAGGED TO ALLOW FURTHER INVESTIGATION. CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED; HOWEVER, THE PATIENT SUBSEQUENTLY PASSED AWAY. IT WAS FURTHER NOTED THAT THE PATIENT HAD EXPERIENCED THREE CARDIAC ARRESTS IN THE EMERGENCY DEPARTMENT PRIOR TO BEING PLACED ON THE G5 VENTILATOR ON JANUARY 17TH. A CAUSAL RELATIONSHIP BETWEEN THE DEVICE BEHAVIOR AND THE PATIENT¿S OUTCOME COULD NOT BE CONFIRMED. DEVICE LOGS SHOWED THE PRESENCE OF TECHNICAL FAULT TF:2441, ALONG WITH DISCONNECTION ALARM. ADDITIONALLY, IT WAS MENTIONED THAT THE USER DID NOT REPORT THE EVENT TO THE LOCAL AUTHORITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676881 HAMILTON G5 HAMILTON G5 CBK HAMILTON MEDICAL AG 159002 07630002802208

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death