BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-C1

    MDR report key: 20105146 · Received August 30, 2024

    Report

    Report Number
    3001421318-2024-02099
    Event Type
    Malfunction
    Date Received
    August 30, 2024
    Date of Event
    August 27, 2024
    Report Date
    May 2, 2025
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002800747
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMES TO THE CONCLUSION: INVESTIGATION ONGOING. G4 WAS CORRECTED IN THIS FOLLOW UP: CORRECT 510K IS K181216. ADDITIONAL INFORMATION ADDED IN FOLLOW-UP #2 CER 156728. FIELD B4, G6, H2, H3, H6 AND H11 UPDATED. DURING START UP AT PREVENTIVE MAINTENANCE THE OPTIONS DISAPPEARED IN CONFIGURATION MENU. NO PATIENT INVOLVED. CONSEQUENTLY, THE EVENT DID NOT CAUSE OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY. THE OPTIONS DISAPPEARED / OPTIONS NOT FOUND ISSUE MANIFESTS DURING DEVICE BOOT-UP, BEFORE THERAPY IS INITIATED OR A PATIENT IS CONNECTED. THEREFORE, IT IS IMMEDIATELY DETECTED, EVEN PRIOR TO ALL MANDATORY TESTS THAT NEED TO BE EXECUTED BEFORE USING THE DEVICE ON A PATIENT. THE ISSUE CAN BE RESOLVED BY STANDARD USER OR SERVICE ACTIONS (E.G., REBOOTING, VERIFYING LICENSE KEYS, OR RELOADING CONFIG). CONSEQUENTLY, THIS MALFUNCTION IS NOT CLASSIFIED AS A CRITICAL FAILURE OR A REPORTABLE EVENT UNDER STANDARD MEDICAL DEVICE REGULATIONS. SINCE IT OCCURS RIGHT AT BOOT UP AND THE VENTILATOR UNDERGOES MANDATORY VALIDATION BEFORE EVERY USE, ANY DEVICE THAT DOES NOT START WILL SIMPLY BE IDENTIFIED AS NON-OPERATIONAL AND REPLACED OR SERVICED BEFORE IT CAN BE CONSIDERED FOR PATIENT CARE.

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMES TO THE CONCLUSION: INVESTIGATION ONGOING.

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMES TO THE CONCLUSION: INVESTIGATION ONGOING. G4 WAS CORRECTED IN THIS FOLLOW UP: CORRECT 510K IS K181216.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY: OPTIONS DISAPPEARED / OPTIONS NOT FOUND.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY: OPTIONS DISAPPEARED / OPTIONS NOT FOUND.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY: OPTIONS DISAPPEARED / OPTIONS NOT FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1356335 HAMILTON-C1 HAMILTON-C1 CBK HAMILTON MEDICAL AG 161001 07630002800747

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown