BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-C1

    MDR report key: 25133950 · Received May 11, 2026

    Report

    Report Number
    3001421318-2026-00273
    Event Type
    Malfunction
    Date Received
    May 11, 2026
    Date of Event
    January 26, 2026
    Report Date
    May 11, 2026
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002800747
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4)

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: THE REPORT FROM HOSPITAL SAY: WHEN THE OXYGEN CONCENTRATION IS SET ABOVE 80% DURING USE, THE OXYGEN CONCENTRATION DETECTION ERROR IS LARGE, AND THE MACHINE WILL ALARM FOR LOW OXYGEN CONCENTRATION AND EMIT A LOUD NOISE - NO HEALTH CONSEQUENCES OR IMPACT - THE STANDBY MACHINE WAS IMMEDIATELY REPLACED. ADDITIONAL INFORMATION RECEIVED ON 1TH MAY 2026: THE REPORT FROM HAMILTON MEDICAL TECHNOLOGIES IN CHINA WAS RECEIVED WHICH PROVIDED NEW INFORMATION ABOUT THE CASE. THE FOLLOWING WAS DESCRIBED: "WHEN THE OXYGEN CONCENTRATION WAS SET ABOVE 80% DURING USE, THERE WAS A LARGE ERROR IN OXYGEN CONCENTRATION DETECTION, AND THE MACHINE ISSUED A LOW OXYGEN CONCENTRATION ALARM AND A ROARING SOUND". THE STANDBY MACHINE WAS IMMEDIATELY REPLACED AND THE MEDICAL EQUIPMENT DEPARTMENT WAS NOTIFIED FOR REPAIR. THE MEDICAL EQUIPMENT DEPARTMENT CONTACTED THE MANUFACTURER'S ENGINEER, AND THE DEVICE RETURNED TO NORMAL AFTER SOFTWARE REINSTALLATION. NO INJURY WAS CAUSED AS THE PROBLEM WAS DETECTED AND THE STANDBY MACHINE WAS REPLACED IMMEDIATELY DURING USE. THE FAILURE MAY BE CAUSED BY A MALFUNCTION AT THE OXYGEN INHALATION VALVE, RESULTING IN THE MIXED OXYGEN CONCENTRATION FAILING TO REACH THE SET VALUE; THE ROARING SOUND MAY BE DUE TO BLOCKAGE AT THE OXYGEN INHALATION VALVE. THERE IS INFORMATION THAT REASONABLY SUGGEST THAT THE DEVICE HAS MALFUNCTIONED AND THAT THE DEVICE OR A SIMILAR DEVICE WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. THEREFORE, REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622038 HAMILTON-C1 HAMILTON-C1 CBK HAMILTON MEDICAL AG 161001 07630002800747

    Patients

    Seq Age Sex Outcome Treatment
    1