BEUDAMED
    FDA Adverse Event Death Summary report: N

    HAMILTON-H900

    MDR report key: 22950410 · Received September 3, 2025

    Report

    Report Number
    3001421318-2025-00781
    Event Type
    Death
    Date Received
    September 3, 2025
    Date of Event
    August 20, 2025
    Report Date
    March 12, 2026
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    BTT
    PMA / PMN Number
    K163283
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG REFERENCE NUMBER: (B)(4). NO SPECIFIC DEVICE MALFUNCTION OR FAILURE WAS REPORTED. THE INFORMATION RECEIVED INDICATES THAT THE PATIENT EXPIRED; HOWEVER, THE CIRCUMSTANCES SURROUNDING THE DEATH REMAIN UNKNOWN, INCLUDING WHETHER THE DEVICE CONTRIBUTED TO THE OUTCOME, AS IT WAS MENTIONED IN COMPLAINT: " NOT KNOWN CONDITIONS OF EXPIRATION (I.E. IF IT WAS EQUIPMENT CAUSED)". IT WAS MENTIONED THAT AN H900 WAS IN USE; HOWEVER, IT COULD NOT BE CONCLUSIVELY CONFIRMED WHETHER A HAMILTON MEDICAL AG VENTILATOR WAS INVOLVED IN THE EVENT. DESPITE SEVERAL FOLLOW-UP REQUESTS AND OUR BEST EFFORTS TO OBTAIN ADDITIONAL INFORMATION, NO FURTHER DETAILS HAVE BEEN PROVIDED. BASED ON THE LIMITED INFORMATION AVAILABLE, NO OBJECTIVE EVIDENCE HAS BEEN IDENTIFIED TO ESTABLISH A CAUSAL RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED PATIENT DEATH. THERE IS INSUFFICIENT INFORMATION TO CONFIRM THAT A DEVICE MALFUNCTION OCCURRED OR THAT THE DEVICE CONTRIBUTED TO THE EVENT. IN THE ABSENCE OF FURTHER INFORMATION, HAMILTON MEDICAL AG CONSIDERS THIS CASE CLOSED. ANY ADDITIONAL RELEVANT INFORMATION RECEIVED IN THE FUTURE WILL BE REVIEWED AND ADDRESSED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG REFERENCE NUMBER: (B)(4). AT THE TIME OF COMPLETING THIS REPORT, THE SERIAL NUMBER OF THE DEVICE IS UNKNOWN. AS A RESULT, THE "PRIMARY UNIQUE DEVICE IDENTIFICATION (UDI) NUMBER" SECTION COULD NOT BE COMPLETED. INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG : NO SPECIFIC FAILURE DESCRIPTION OF THE DEVICE WAS PROVIDED. HOWEVER, IT WAS NOTED THAT THE PATIENT EXPIRED. THE CIRCUMSTANCES SURROUNDING THE EXPIRATION REMAIN UNKNOWN, INCLUDING WHETHER THE DEVICE CONTRIBUTED TO THE OUTCOME, AS IT WAS MENTIONED IN COMPLAINT: " NOT KNOWN CONDITIONS OF EXPIRATION (I.E. IF IT WAS EQUIPMENT CAUSED)". WHILE IT IS UNCLEAR IF A HAMILTON MEDICAL AG VENTILATOR WAS INVOLVED, IT WAS MENTIONED THE H900 WAS IN USE. ACCORDING TO THE INFORMATION RECEIVED, MEDICAL INTERVENTION WAS NECESSARY, THOUGH NO FURTHER CLINICAL DETAILS WERE PROVIDED. THE EVENT WAS REPORTED TO THE LOCAL AUTHORITY; HOWEVER, THE REFERENCE NUMBER WAS NOT PROVIDED. DESPITE SEVERAL FOLLOW-UP REQUESTS AND OUR BEST EFFORTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS CASE, NO FURTHER DETAILS HAVE BEEN PROVIDED TO DATE.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: NO SPECIFIC FAILURE DESCRIPTION OF THE DEVICE WAS PROVIDED. HOWEVER, IT WAS NOTED THAT THE PATIENT EXPIRED. THE CIRCUMSTANCES SURROUNDING THE EXPIRATION REMAIN UNKNOWN, INCLUDING WHETHER THE DEVICE CONTRIBUTED TO THE OUTCOME, AS IT WAS MENTIONED IN COMPLAINT: " NOT KNOWN CONDITIONS OF EXPIRATION (I.E. IF IT WAS EQUIPMENT CAUSED)". WHILE IT IS UNCLEAR IF A HAMILTON MEDICAL AG VENTILATOR WAS INVOLVED, IT WAS MENTIONED THE H900 WAS IN USE. ACCORDING TO THE INFORMATION RECEIVED, MEDICAL INTERVENTION WAS NECESSARY, THOUGH NO FURTHER CLINICAL DETAILS WERE PROVIDED. THE INCIDENT WAS REPORTED TO THE LOCAL AUTHORITY; HOWEVER, THE REFERENCE NUMBER WAS NOT PROVIDED. DUE TO LIMITED AVAILABLE INFORMATION, FURTHER INQUIRIES HAVE BEEN SENT TO THE CUSTOMER TO OBTAIN ADDITIONAL DETAILS REGARDING THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608939 HAMILTON-H900 HAMILTON-H900 BTT HAMILTON MEDICAL AG 950004

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death