BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-G5

    MDR report key: 21352327 · Received February 11, 2025

    Report

    Report Number
    3001421318-2025-00263
    Event Type
    Malfunction
    Date Received
    February 11, 2025
    Date of Event
    January 31, 2025
    Report Date
    February 11, 2025
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    PMA / PMN Number
    K193228
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP 1: DEVICE EVALUATION. HAMILTON MEDICAL AG RECEIVED THE LOGFILES OF THE DEVICE FOR ANALYSIS. ALL IMPORTANT ACTIONS SUCH AS OPERATOR SETTINGS, ACTIONS AND ALARMS, ETC. ARE DOCUMENTED IN THE LOGFILES. BASED ON THE ANALYSIS OF THE LOG FILES, THERE IS NO RECORD OF A HIGH/LOW OXYGEN ALARM ON (B)(6) 2025. HOWEVER, THE LOG FILES INDICATE THAT THE DEVICE REGISTERED AN "OXYGEN + AIR SUPPLIES FAILED" ALARM ON (B)(6) 2025. BELOW IS AN EXTRACT FROM THE LOG FILES FOR REFERENCE: LINE 204: (B)(6) 2025 15:16:41 OXYGEN + AIR SUPPLIES FAILED SUPPLY 5017. LINE 209: (B)(6) 2025 14:30:10 OXYGEN SUPPLY FAILED SUPPLY 5016. LINE 251: (B)(6) 2025 13:51:58 OXYGEN 50 % SETTING 302. LINE 256: (B)(6) 2025 13:51:58 OXYGEN HIGH IS OFF SETTING 132. LINE 375: (B)(6) 2025 10:55:22 OXYGEN + AIR SUPPLIES FAILED SUPPLY 5017. LINE 376: (B)(6) 2025 10:55:22 OXYGEN SUPPLY FAILED SUPPLY 5016. LINE 416: (B)(6) 2025 22:42:23 OXYGEN 40 % SETTING 302. THE EVENT DID NOT OCCUR DURING VENTILATION. NEVERTHELESS, IF SUCH AN EVENT WERE TO OCCUR DURING VENTILATION, THE THERAPY MIGHT BE AFFECTED AND THEREFORE A POTENTIAL DETERIORATION IN THE PATIENT' STATE OF HEALTH CANNOT BE EXCLUDED. THEREFORE, THIS EVENT IS CONSIDERED REPORTABLE. THE SERVICE TECHNICIAN CONDUCTED TROUBLESHOOTING AND IDENTIFIED THE ROOT CAUSE AS A DEFECTIVE AIR/O ² MIXER VALVES. CONSEQUENTLY, THE DEFECTIVE MIXER VALVES WAS REPLACED. AFTER THE REPLACEMENT, THE DEVICE FUNCTIONED CORRECTLY.

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMPLAINT NUMBER (B)(4). CREATION OF UDI WAS NOT A REQUIREMENT AT THE TIME OF MANUFACTURING OF THIS DEVICE AND HAD NOT YET BEEN IMPLEMENTED IN PRODUCTION. INVESTIGATION ONGOING.

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING DESCRIPTION: ACCORDING TO THE INFORMATION RECEIVED FROM THE CUSTOMER, THE DEVICE ALARMED WITH HIGH / LOW OXYGEN ALARM. HOWEVER, BASED ON THE LOG FILES REVIEW, IT HAS BEEN DETERMINED THAT THERE IS NO RECORD OF A HIGH/LOW OXYGEN ALARM ON (B)(6) 2025. NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING DESCRIPTION: ACCORDING TO THE INFORMATION RECEIVED FROM THE CUSTOMER, THE DEVICE ARMED WITH HIGH / LOW OXYGEN ALARM. HOWEVER, BASED ON THE LOG FILES REVIEWED, THERE IS NO RECORD OF A HIGH/LOW OXYGEN ALARM ON THE SPECIFIED DATE ((B)(6) 2025). THE LOG FILES SHOWED THAT THE DEVICE ALARMED WITH "OXYGEN + AIR SUPPLIES FAILED". CONSEQUENTLY, THE MANUFACTURER IS CURRENTLY IN THE PROCESS OF OBTAIN MORE INFORMATION ABOUT THE INCIDENT AND THE ACTUAL FAILURE THAT OCCURRED. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1753538 HAMILTON-G5 HAMILTON-G5 CBK HAMILTON MEDICAL AG 159001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown