BEUDAMED
    FDA Adverse Event Death Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 17223400 · Received June 29, 2023

    Report

    Report Number
    3001421318-2023-02489
    Event Type
    Death
    Date Received
    June 29, 2023
    Date of Event
    June 26, 2023
    Report Date
    August 21, 2023
    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
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMES TO THE CONCLUSION: HAMILTON MEDICAL AG CONSIDERED THIS CER (B)(4) NO RISK ID WITH NO SEVERITY AS A REPORTABLE EVENT AT THE TIME OF THE REPORT. THE ROOT CAUSE ANALYSIS ON THE LOGFILES ANALYSIS DOES NOT DETERMINE THAT HAMILTON-C6 FAILED TO DELIVER THE THERAPY TO THE PATIENT. NO TECHNICAL ISSUES DURING THE VENTILATION WERE TRACKED IN THE LOG FILE. THE DEVICE WORKED AS INTENDED, THERE WAS NO MALFUNCTION OF THE DEVICE. FURTHER CLINICAL EVALUATION BY HAMILTON MEDICAL AG IS NOT POSSIBLE BUT IS ALSO NOT NECESSARY BECAUSE THE CLINICAL COURSE OF THE PATIENT IS NOT RELATED TO THE HAMILTON-C6. HAMILTON MEDICAL AG IS NOT ABLE TO EVALUATE ANY CLINICAL INFORMATION BECAUSE ANY INFORMATION WAS NOT GIVEN DUE TO THE PRIVACY OF PERSONAL INFORMATION. HAMILTON MEDICAL AG COULD NOT EVALUATE THE CAUSE OF THE DEATH. THE VENTILATOR WAS TAKEN OUT OF SERVICE. ALL TECHNICAL SERVICE SOFTWARE HAS BEEN PERFORMED DURING THE INSTALLATION AND DOCUMENTED WITH NO DEVIATION. NO FURTHER ANALYSIS WAS PERFORMED AT THE DATE OF THIS INVESTIGATION REPORT. NO REPLACEMENT PARTS WERE REPLACED ACCORDING TO THE REPORT. THE VENTILATOR HAS NOT BEEN CONFIRMED YET AND IS BACK IN SERVICE. THIS COMPLAINT IS CONSIDERED NOT REPORTABLE BECAUSE THERE WAS NO MALFUNCTION OF THE DEVICE DETECTED. WITH THIS INVESTIGATION, IT IS CONFIRMED THAT THE DEVICE DID NOT FAIL TO MEET ITS SPECIFICATIONS AT THE TIME OF THE EVENT WHILE THE VENTILATOR WAS IN USE WITH A PATIENT. PATIENT HARM OR INVOLVEMENT HAS BEEN CONFIRMED. BASED ON THE ANALYSIS, NO DEVICE MALFUNCTION OR TECHNICAL FAULT CONTRIBUTE TO THE ISSUE. ALSO, THERE WAS NO DEVICE-RELATED EVENT THAT MAY HAVE CAUSED USER CONFUSION LEADING TO THE USER'S DECISION TO REDUCE THE SETTING FROM 100% TO 30%. HENCE, THERE WAS NO HAZARDOUS SITUATION TO WHICH THE VENTILATOR CONTRIBUTED. THE DEVICE WORKED AS INTENDED. FOLLOWING THE INVESTIGATION, THE INITIAL REPORTABLE EVENT NOW IS CONSIDERED TO BE A COMPLAINT. NO FURTHER INVESTIGATION OR CORRECTION WILL BE PERFORMED EXCEPT THOSE MENTIONED ABOVE. HAMILTON MEDICAL AG DEMONSTRATES "GOOD FAITH" IN ANY FAILED ATTEMPTS TO OBTAIN REQUIRED DATA AND A "GOOD EFFORT FAITH" TO OBTAIN ADDITIONAL INFORMATION INCLUDING A REQUEST BY E-MAIL TO REQUEST INFORMATION FOR THE REPORTABLE EVENT.

    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: SUMMARY: FIO2 SETTING SPONTANEOUSLY CHANGED BY VENTILATOR. PATIENT PASSED AWAY.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY: FIO2 SETTING SPONTANEOUSLY CHANGED BY VENTILATOR. PATIENT PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1562470 HAMILTON MEDICAL AG HAMILTON-C6 VENTILATOR CBK HAMILTON MEDICAL AG 160021 07630002808590

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death