BEUDAMED
    FDA Adverse Event Death Summary report: N

    HAMILTON-C6

    MDR report key: 18289472 · Received December 8, 2023

    Report

    Report Number
    3001421318-2023-04112
    Event Type
    Death
    Date Received
    December 8, 2023
    Date of Event
    October 31, 2023
    Report Date
    September 25, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002808590
    PMA / PMN Number
    K201658
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMES TO THE CONCLUSION: ROOT CAUSE: PRESSURE SENSOR ASSEMBLY DEFECTIVE. CORRECTION: REPLACED PRESSURE SENSOR ASSEMBLY. HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4). FOLLOW-UP 1 - CORRECTED INFORMATION:  UDI RELATED DATA QUALITY UPDATES ONLY. FIELD D4 WAS UPDATED WITH FULL UDI INFORMATION.

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMES TO THE CONCLUSION: ROOT CAUSE: PRESSURE SENSOR ASSEMBLY DEFECTIVE. CORRECTION: REPLACED PRESSURE SENSOR ASSEMBLY.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: DETAILED COMPLAINT AND FAILURE DESCRIPTION: DEVICE WITH PROBLEMS IN THE STARTUP SELF-TEST, SELF-TEST ALARM IS DISPLAYED.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: DETAILED COMPLAINT AND FAILURE DESCRIPTION: DEVICE WITH PROBLEMS IN THE STARTUP SELF-TEST, SELF-TEST ALARM IS DISPLAYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759275 HAMILTON-C6 HAMILTON-C6 VENTILATOR CBK HAMILTON MEDICAL AG 160021 07630002808590

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death