BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 16528791 · Received March 13, 2023

    Report

    Report Number
    3001421318-2023-00616
    Event Type
    Injury
    Date Received
    March 13, 2023
    Date of Event
    March 8, 2023
    Report Date
    April 22, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002800372
    PMA / PMN Number
    K201658
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DETAILED INVESTIGATION WAS PERFORMED BY AN EXPERT FROM THE TECHNICAL SERVICE: NO FURTHER INVESTIGATION OR CORRECTION WILL BE PERFORMED EXCEPT THOSE MENTIONED ABOVE. THE ALLEGATION IN THIS COMPLAINT WAS CONFIRMED TO BE A COMPLAINT. THE ROOT CAUSE COULD NOT BE DETERMINED. IN CONSEQUENCE THE PATIENT WAS MANUALLY BAGGED, AND ALLEGEDLY AN ALTERNATIVE DEVICE WAS USED. HOWEVER, THERE IS NO INDICATION FOR THAT SINCE THE LOGFILES SHOW USAGE OF THE AFFECTED VENTILATOR UNTIL THE DAY AFTER. THERE WAS PATIENT HARM IN THE FORM OF CYANOSIS AND BLEEDING. HOWEVER, THE CAUSALITY BETWEEN THE HARM AND THE DEVICE WAS NOT ESTABLISHED. THIS INCIDENT WAS INITIALLY REPORTED TO THE FDA (REF: (B)(4)).

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMES TO THE CONCLUSION: THE INVESTIGATION OF THE LOGFILES SHOWED THAT THE VENTILATOR ALARMED ACCORDING TO THE LOG FILES. AS WELL NO TF (TECHNICAL FAULT) WAS LOGGED. NO FURTHER CORRECTIVE ACTION WAS NEEDED SINCE DEVICE HAS BEEN PASSED ALL TESTS AND CALIBRATIONS BEFORE GETTING BACK TO USAGE. NO FURTHER INFORMATION WAS PROVIDED TO INVESTIGATE THE INCIDENT FURTHER. NO ROOT CAUSE COULD BE IDENTIFIED, BECAUSE OF INSUFFICIENT INFORMATION. THERE WAS NO CONFIRMATION THAT THE HARM OCCURRED IS RELATED TO THE VENTILATION. DESPITE SEVERAL ATTEMPTS WE COULD NOT RECEIVE FURTHER INFORMATION.

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMES TO THE CONCLUSION: INVESTIGATION ONGOING.

    Description of Event or Problem · 0

    THE PATIENT IS ON DAY 8 AFTER HEART SURGERY. TRACE OSTOMY WITHOUT REMARK THE SAME DAY IN THE MORNING. VENTILATION MODE ASV 45% OXYGEN. 19.30 THE PATIENT BECOMES INCREASINGLY CIRCULATORY UNSTABLE ARTERIAL GAS + HB NORMAL. SHORTLY AFTER CIRCULATORY DETERIORATION. THE PATIENT IS FOUND TO BE CYANOTIC. THE RESPIRATOR DOES NOT INTRODUCE VOLUMES AND DOES NOT SOUND AN ALARM. HOSES AND CORDS ARE CHECKED WITHOUT COMMENT. TRIES MODE PVC+ , NO VOLUMES IN, NO AUDIBLE ALARMS. HAND VENTILATED WITHOUT REMARK. HEART LUNG RESCUE BEGINS. SWITCH TO ANOTHER VENTILATOR, THEN VENTILATE WITHOUT COMMENT UNTIL THE SURGEON ARRIVES. EMERGENCY OPENING TAKES PLACE IN THE HALL. WHEN TAMPONADE OCCURS, APPROXIMATELY 1 LITER OF BLOOD IS DRAINED. RESTORES CIRCULATION.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO THE HAMILTON MEDICAL AG: ORIGINAL COMPLAINT: THE PATIENT IS ON DAY 8 AFTER HEART SURGERY. TRACE OSTOMY WITHOUT REMARK THE SAME DAY IN THE MORNING. VENTILATION MODE ASV 45% OXYGEN. 19.30 THE PATIENT BECOMES INCREASINGLY CIRCULATORY UNSTABLE ARTERIAL GAS + HB NORMAL. SHORTLY AFTER CIRCULATORY DETERIORATION. THE PATIENT IS FOUND TO BE CYANOTIC. THE RESPIRATOR DOES NOT INTRODUCE VOLUMES AND DOES NOT SOUND AN ALARM. HOSES AND CORDS ARE CHECKED WITHOUT COMMENT. TRIES MODE PVC+ , NO VOLUMES IN, NO AUDIBLE ALARMS. HAND VENTILATED WITHOUT REMARK. HEART LUNG RESCUE BEGINS. SWITCH TO ANOTHER VENTILATOR, THEN VENTILATE WITHOUT COMMENT UNTIL THE SURGEON ARRIVES. EMERGENCY OPENING TAKES PLACE IN THE HALL. WHEN TAMPONADE OCCURS, APPROXIMATELY 1 LITER OF BLOOD IS DRAINED. RESTORES CIRCULATION.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO THE HAMILTON MEDICAL AG: ORIGINAL COMPLAINT: THE PATIENT IS ON DAY 8 AFTER HEART SURGERY. TRACE OSTOMY WITHOUT REMARK THE SAME DAY IN THE MORNING. VENTILATION MODE ASV 45% OXYGEN. 19.30 THE PATIENT BECOMES INCREASINGLY CIRCULATORY UNSTABLE ARTERIAL GAS + HB NORMAL. SHORTLY AFTER CIRCULATORY DETERIORATION. THE PATIENT IS FOUND TO BE CYANOTIC. THE RESPIRATOR DOES NOT INTRODUCE VOLUMES AND DOES NOT SOUND AN ALARM. HOSES AND CORDS ARE CHECKED WITHOUT COMMENT. TRIES MODE PVC+, NO VOLUMES IN, NO AUDIBLE ALARMS. HAND VENTILATED WITHOUT REMARK. HEART LUNG RESCUE BEGINS. SWITCH TO ANOTHER VENTILATOR, THEN VENTILATE WITHOUT COMMENT UNTIL THE SURGEON ARRIVES. EMERGENCY OPENING TAKES PLACE IN THE HALL. WHEN TAMPONADE OCCURS, APPROXIMATELY 1 LITER OF BLOOD IS DRAINED. RESTORES CIRCULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514418 HAMILTON MEDICAL AG HAMILTON-C6 CBK HAMILTON MEDICAL AG HAMILTON-C6 07630002800372

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention