BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-C6

    MDR report key: 21341559 · Received February 10, 2025

    Report

    Report Number
    3001421318-2025-00254
    Event Type
    Malfunction
    Date Received
    February 10, 2025
    Date of Event
    January 24, 2025
    Report Date
    August 19, 2025
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002800372
    PMA / PMN Number
    K201658
    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`S CONCLUSION: INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: ADDED MISSED 510K NUMBER: K201658.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: HAMILTON MEDICAL COMES TO THE FOLLOWING CONCLUSION: THE EVENT HAPPENED DURING STARTUP OF THE VENTILATOR, WHERE THE USER OBSERVED TECHNICAL EVENTS (TE) 231007 (TAGD_O2CONTROLLERFLOWHIGH) AND TE 231008 (TAGD_O2VALVELEAK) WITHOUT PATIENT INVOLVEMENT. ADDITIONALLY, THE USER REPORTED AN AUDIBLE O2 LEAK AND A FAILED SELF-TEST, WITH SENSOR DATA SHOWING AN UNEXPECTED QO2 FLOW OF ~17 L/MIN DESPITE THE FLOW BEING SET TO ZERO.LOGFILE ANALYSIS SHOWED THAT NO AMBIENT MODE WAS TRIGGERED, AND THE EVENTS WERE ISOLATED TO THE O2 MIXER BLOCK, WHICH SHOWED DEVIATION DURING CALIBRATION. THE ROOT CAUSE WAS A DEFECTIVE CONTROL VALVE WITHIN THE MIXER ASSEMBLY. THE O2 MIXER BLOCK WAS REPLACED RESOLVING THE ISSUE. NO PATIENT WAS HARMED, AND THE VENTILATOR WAS RESTORED TO FULL FUNCTION AND RETURNED TO CLINICAL USE. CORRECTION: UPDATED IMDRF CODING IN SECTION H6.

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING: (1) COMPLAINT DESCRIPTION (QUATATION FROM THE CUSTOMER/REPORTER): "AFTER STARTUP DEVICE GIVES 231007 (O2 CONTROLLER FLOW HIGH) AND 231008 (O2 VALVE LEAK) TECHNICAL EVENT. CAN HEAR THAT HPO O2 IS LEAKING SOMEWHERE. FROM SERVICE MENU - SENSOR DATA - FLOW SENSOR QO2 IS SHOWING ~17L/MIN EVEN WHEN FLOW IS SET TO 0." (2) HEALTH IMPACT: NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    959596 HAMILTON-C6 HAMILTON-C6 CBK HAMILTON MEDICAL AG 160021 07630002800372

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown