BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-C6

    MDR report key: 24798281 · Received April 7, 2026

    Report

    Report Number
    3001421318-2026-00197
    Event Type
    Malfunction
    Date Received
    April 7, 2026
    Date of Event
    March 29, 2026
    Report Date
    April 7, 2026
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002808590
    PMA / PMN Number
    K201658
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG REF. NR: (B)(4). LOGFILE ANALYSIS CONFIRMED THAT THE DEVICE EXPERIENCED A TECHNICAL FAILURE DURING ACTIVE NEONATAL VENTILATION, WHERE A CLUSTER OF TECHNICAL FAULTS (TF446029, TF1746004, TF432001, TF1446029, TF1485001) OCCURRED SHORTLY AFTER VENTILATION START, LEADING TO TRANSITION TO AMBIENT STATE AND INTERRUPTION OF VENTILATION. THE DEVICE WAS IMMEDIATELY RESTARTED AND VENTILATION RESUMED; HOWEVER, RECURRENT TECHNICAL EVENT 232006 WAS OBSERVED DURING CONTINUED OPERATION, FOLLOWED BY A SECOND OCCURRENCE OF THE SAME FAULT CLUSTER IN STANDBY, AFTER WHICH THE DEVICE WAS POWERED. HISTORICAL LOGS ALSO SHOW REPEATED OCCURRENCE OF TECHNICAL EVENT 232006, INCLUDING PERSISTENCE DURING SUBSEQUENT STARTUPS AND A SELF-TEST FAILURE ON 31-03-2026. INVESTIGATION ONGOING.

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: THE EVENT WAS REPORTED AS A TECHNICAL EVENT INVOLVING BLOWER AND MAINBOARD, WITH HIGH BLOWER TEMPERATURE READING AND AMBIENT FAILURE DURING VENTILATION. NO HARM TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864037 HAMILTON-C6 HAMILTON-C6 CBK HAMILTON MEDICAL AG 160021 07630002808590

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown