BEUDAMED
    FDA Adverse Event Death Summary report: N

    HAMILTON-C1

    MDR report key: 20236983 · Received September 17, 2024

    Report

    Report Number
    3001421318-2024-02240
    Event Type
    Death
    Date Received
    September 17, 2024
    Date of Event
    September 9, 2024
    Report Date
    December 19, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    PMA / PMN Number
    K181216
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG CASE NUMBER IS: (B)(4). THE INDICATED DEATH OF THE PATIENT WAS DUE TO SEPSIS. THE CASE IS CURRENTLY UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG CASE NUMBER IS: (B)(4). FOLLOW-UP NR. 1 INFORMATION: THE FOLLOWING SECTIONS WERE CHANGED, ADDED IN THIS FOLLOW-UP MDR: B4, G3, G6, H2, H6, H11 INVESTIGATION: THE INDICATED DEATH OF THE PATIENT WAS DUE TO SEPSIS. THERE IS NO RELATION BETWEEN THE DESATURATION EVENT AS MENTIONED ABOVE AND THE REPORTED SEPSIS. THE MOST PROBABLE ROOT CAUSE IS A USE ERROR. ACCORDING TO THE LOGFILE ANALYSIS IT SEEMS THAT THE USER DID NOT ADEQUATELY REACT TO THE ALARM BY EITHER CHECKING THE OXYGEN SUPPLY OR PROVIDING AN ALTERNATIVE SOURCE OF OXYGEN. WITH THIS INVESTIGATION IT HAS BEEN CONFIRMED THAT THE DEVICE DID NOT FAIL TO MEET ITS SPECIFICATIONS AT THE TIME OF THE EVENT WHILE THE VENTILATOR WAS IN USE.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: DIFFICULT PATIENT WAS VENTILATED WITH MASK NIV AT THE BEGINNING. AFTER INTUBATION, THE PATIENT WAS SWITCHED TO NIV-ST, AFTER WHICH THE PATIENT WAS DESATURATED (TURNED BLUE) AND WHEN 100% O2 WAS SET ON THE DEVICE, IT INDICATED "NO OXYGEN SUPPLY". THE PATIENT WAS THEN FURTHER VENTILATED WITH A RESUSCITATOR AND AN ALTERNATIVE OXYGEN SOURCE. THE DEVICE WAS BROUGHT INTO MEDICAL TECHNOLOGY. THE PATIENT DIED OF SEPSIS TWO DAYS LATER. THERE IS NO RELATION BETWEEN THE DESATURATION EVENT AS MENTIONED ABOVE AND THE REPORTED SEPSIS. THEREFORE THE CODE F02 WAS NOT SELECTED BELOW.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: DIFFICULT PATIENT WAS VENTILATED WITH MASK NIV AT THE BEGINNING. AFTER INTUBATION, THE PATIENT WAS SWITCHED TO NIV-ST, AFTER WHICH THE PATIENT WAS DESATURATED (TURNED BLUE) AND WHEN 100% O2 WAS SET ON THE DEVICE, IT INDICATED "NO OXYGEN SUPPLY". THE PATIENT WAS THEN FURTHER VENTILATED WITH A RESUSCITATOR AND AN ALTERNATIVE OXYGEN SOURCE. THE DEVICE WAS BROUGHT INTO MEDICAL TECHNOLOGY. THE PATIENT DIED OF SEPSIS TWO DAYS LATER. THERE IS NO RELATION BETWEEN THE DESATURATION EVENT AS MENTIONED ABOVE AND THE REPORTED SEPSIS. THEREFORE, THE CODE F02 WAS NOT SELECTED BELOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1808600 HAMILTON-C1 HAMILTON-C1 CBK HAMILTON MEDICAL AG 161001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| D