BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-C6

    MDR report key: 24870826 · Received April 14, 2026

    Report

    Report Number
    3001421318-2026-00213
    Event Type
    Malfunction
    Date Received
    April 14, 2026
    Date of Event
    April 6, 2026
    Report Date
    April 14, 2026
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002808590
    PMA / PMN Number
    K201658
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG REFERENCE NUMBER: (B)(4). THE REPORT CONTAINS ALSO THE INVESTIGATION OUTCOME. IT WAS REPORTED THAT THE DEVICE WAS VENTILATING THE PATIENT WHEN IT SUDDENLY STOPPED. THE DEVICE THEN DISPLAYED MULTIPLE ALARMS RELATED TO THE BLOWER. THE VENTILATOR WAS SUBSEQUENTLY EXCHANGED. NO PATIENT HARM WAS REPORTED. HAMILTON MEDICAL AG RECEIVED AND ANALYZED THE DEVICE LOG FILES. THE ANALYSIS CONFIRMED THAT DURING VENTILATION, TECHNICAL FAULT (TF) 431001 ¿ BLOWER FAULT AND TF 446029 ¿ AMBIENT FAILURE DETECTED WERE TRIGGERED. PLEASE SEE BELOW AN EXTRACT FROM THE LOGFILES 117/2026-04-06 12:14:15/POWER /OFF VENTILATION SOFTWARE 118/2026-04-06 12:13:32/TF /446029 119/2026-04-06 12:13:32/TF /1746004 120/2026-04-06 12:13:32/TF /431001 121/2026-04-06 12:13:32/TF /1446029 122/2026-04-06 12:13:32/TF /1485001 THE SERVICE TECHNICIAN REPLACED THE BLOWER MODULE. FOLLOWING THE REPAIR, THE DEVICE SUCCESSFULLY PASSED ALL SERVICE SOFTWARE CHECKS AND WAS RETURNED TO CLINICAL USE. HAMILTON MEDICAL AG CONSIDERS THIS CASE CLOSED.

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING DESCRIPTION: THE DEVICE WAS VENTILATING THE PATIENT WHEN IT STOPPED SUDDENLY. THE DEVICE WAS SHOWING MULTIPLE ALARMS RELATED TO THE BLOWER. THE VENTILATOR WAS REPLACED WITH ANOTHER ONE. NO HARM TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    930685 HAMILTON-C6 HAMILTON-C6 CBK HAMILTON MEDICAL AG 160021 07630002808590

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown