BEUDAMED
    FDA Adverse Event Death Summary report: N

    HAMILTON-C6

    MDR report key: 18593886 · Received January 29, 2024

    Report

    Report Number
    3001421318-2024-00214
    Event Type
    Death
    Date Received
    January 29, 2024
    Date of Event
    January 10, 2024
    Report Date
    September 5, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002808590
    PMA / PMN Number
    K201658
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMES TO THE CONCLUSION: ROOTCAUSE: THE ROOT CAUSE AND WHAT EXACTLY HAPPENED COULD NOT BE DETERMINED BECAUSE THE VENTILATOR WAS SEIZED BY AUTHORITIES AND NEITHER THE DEVICE ITSELF NOR THE LOGFILES ARE ACCESSIBLE FOR ANALYSIS. NO FURTHER ACTIONS CAN BE INITIATED DUE TO LACK OF INFORMATION. WITH THE INFORMATION AVAILABLE AND WITHOUT LOG FILES OF THE DEVICE INVOLVED THAT REFLECT THE SITUATION AT THE TIME OF THE EVENT, WE CANNOT CURRENTLY SEE A CAUSAL CONNECTION BETWEEN THE PATIENT HARM AND THE DEVICE USED TO VENTILATE THE PATIENT. WHEN THE VENTILATOR, BLOCKED BY THE POLICE, IS RELEASED FOR ACCESS AND AS SOON AS WE HAVE THE EVENT LOGS OF THE DEVICE FOR ANALYSIS, WE WILL RE-EVALUATE THE INFORMATION. HAMILTON MEDICAL AG WAS NEVER INFORMED ABOUT THE FURTHER COURSE OF THE TREATMENT AND POSSIBLE PERMANENT DAMAGE TO THE PATIENT. TO DATE AND DESPITE REPEATED REQUESTS TO PROVIDE THE LOG FILES, IT HAS NOT BEEN POSSIBLE TO RETRIEVE THE VENTILATOR'S LOG FILES AS AUTHORITIES HAVE NOT RELEASED THE DEVICE FOR INVESTIGATION. WITHOUT THE LOG FILES, NO INVESTIGATION CAN TAKE PLACE. CORRECTION: YET THE NEED FOR ANY CORRECTION COULD BE DERIVED. NOTE: CORRECTED SECTION D1 AND D4.

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMES TO THE CONCLUSION: INVESTIGATION ONGOING.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: DETAILED COMPLAINT AND FAILURE DESCRIPTION: "AFTER A CARDIAC SURGERY THE PATIENT WAS CONNECTED TO THE C6 VENTILATOR WITH SN (B)(6) FROM (B)(6) 2024 TO (B)(6) 2024. DUE BREATHING ISSUE (SUSPECT PNEUMONIA) THE PATIENT WAS CONNECTED AGAIN TO THE C6 VENTILATOR WITH SN (B)(6) ON (B)(6) 2024. ON (B)(6) 2024 AT 5.50 PM THE PROFESSOR (B)(6) AND DR. (B)(6) CAME PROMPTLY ALERTED BY THE NURSE ON DUTY AT THE (B)(6) UNIT BECAUSE THE PATIENT PRESENTED EXTREME BRADYCARDIA AND SUBSEQUENT CARDIAC ARREST. THEY PERFORM RESUSCITATION MANEUVERS. IN THIS CONTEXT THE DOCTORS FOUND THE VENTILATOR IN STANDBY. AFTER THE RESUSCITATION MANEUVER, THE PATIENT HE WAS SUBJECTED TO A MECHANICS VENTILATION AGAIN WITH ANOTHER C6 VENTILATOR. TILL NOW IS IMPOSSIBLE TO DOWNLOAD THE LOG FILES FROM THE VENTILATOR BECAUSE THE DEVICE IS UNDER SEIZURE BY THE POLICE."

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: DETAILED COMPLAINT AND FAILURE DESCRIPTION: "AFTER A CARDIAC SURGERY THE PATIENT WAS CONNECTED TO THE C6 VENTILATOR WITH SN (B)(6) FROM (B)(6) 2024. DUE BREATHING ISSUE (SUSPECT PEUMONIA) THE PATIENT WAS CONNECTED AGAIN TO THE C6 VENTILATOR WITH SN (B)(6) ON (B)(6) 2024. ON (B)(6) 2024 AT 5.50 PM THE PROFESSOR (B)(6) CAME PROMPTLY ALERTED BY THE NURSE ON DUTY AT THE (B)(6) ANESTHESIA AND CARDIO-THORACO-VASCULAR UNIT BECAUSE THE PATIENT PRESENTED EXTREME BRADYCARDIA AND SUBSEQUENT CARDIAC ARREST. THEY PERFORM RESUSCITATION MANEUVERS. IN THIS CONTEXT THE DOCTORS FOUND THE VENTILATOR IN STANDBY. AFTER THE RESUSCITATION MANEUVRE, THE PATIENT HE WAS SUBJECTED TO A MECHANICS VENTILATION AGAIN WITH ANOTHER C6 VENTILATOR. TILL NOW IS IMPOSSIBLE TO DOWNLOAD THE LOG FILES FROM THE VENTILATOR BECAUSE THE DEVICE IS UNDER SEIZUER BY THE POLICE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797717 HAMILTON-C6 HAMILTON-C6 CBK HAMILTON MEDICAL AG 160021 07630002808590

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death