BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON G5

    MDR report key: 21501876 · Received March 3, 2025

    Report

    Report Number
    3001421318-2025-00358
    Event Type
    Malfunction
    Date Received
    March 3, 2025
    Date of Event
    February 13, 2025
    Report Date
    September 25, 2025
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    PMA / PMN Number
    K193228
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP 1: ADDITIONAL INFORMATION RECEIVED: UPDATED FIELDS: B1, B4, B5, E4, G3, G6, H1, H2, H6. INVESTIGATION ONGOING.

    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.

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG REFERENCE NUMBER: (B)(4). FOLLOW-UP 2 : 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. ACCORDING TO THE LOG FILE ANALYSIS, A LOSS OF MAIN POWER ALARM WAS RECORDED, FOLLOWED BY A POWER FAILURE ON (B)(6) 2025. ON (B)(6) 2025, 15:10:45 RESTART AFTER POWER FAIL (B)(6) 2025 POWER 2, ON (B)(6) 2025, 15:10:22 POWER FAIL (B)(6) 2025 POWER 4, ON (B)(6) 2025, 15:10:21 AUDIO PAUSED OFF SPECIAL 517, ON (B)(6) 2025, 15:10:21 LOSS OF MAINS POWER SUPPLY 3087, ON (B)(6) 2025, 15:09:12 AUDIO PAUSED ON SPECIAL 516, ON (B)(6) 2025,15:06:11 LOW MINUTE VOLUME ALARMS 5006, ON (B)(6) 2025, 15:05:58 DISCONNECTION ON VENTILATOR SIDE ALARMS 5011, ON (B)(6) 2025, 15:05:58 LOSS OF PEEP ALARMS 4001, ON (B)(6) 2025, 15:05:52 TF : 1629 1857 TECH FAULT 1629, ON (B)(6) 2025,15:05:51 NEBULIZER PNEUMATIC SETTING 349, ON (B)(6) 2025, 15:05:50 TF : 1629 1857 TECH FAULT 1629, ON (B)(6) 2025, 15:05:45 INTELLICUFF MODE OFF SPECIAL 535, ON (B)(6) 2025, 15:05:45 INTELLICUFF MODE OFF SPECIAL 535, ON (B)(6) 2025, 15:05:45 NEBULIZER OFF SPECIAL 501, ON (B)(6)2025, 15:05:45 OPTIONS HLI OFF SPECIAL 526, ON (B)(6)2025, 15:05:45 P-RAMP 50 MS SETTING 306, ON (B)(6)2025, 15:05:45 FLOWTRIGGER 3.0 L/MIN SETTING 304, ON (B)(6)2025, 15:05:45 %TI 33 % SETTING 309, ON (B)(6)2025, 15:05:45 OXYGEN 100 % SETTING 302, ON (B)(6)2025, 15:05:45 PEEP/CPAP 10.0 CMH2O SETTING 301, ON (B)(6)2025, 15:05:45 ¿PCONTROL 10 CMH2O SETTING 307, ON (B)(6)2025, 15:05:45 RATE 10 B/MIN SETTING 314, ON (B)(6)2025, 15:05:45 VENTILATION MODE P-CMV SETTING 220, ON (B)(6)2025, 15:05:45 LAST SETUP SETTING 201, ON (B)(6)2025, 15:05:45 OPERATING TIME: 12 HOUR(S) 43 MINUTE(S) DEVICE 825, ON (B)(6)2025,15:05:45 OPERATING TIME: 482 DAY(S) DEVICE 826, ON (B)(6)2025, 15:05:45 RESTART AFTER POWER FAIL (B)(6) 2025 POWER 2, ON (B)(6)2025,15:05:19 POWER FAIL (B)(6) 2025 POWER 4, ON (B)(6)2025, 15:05:15 LOSS OF MAINS POWER SUPPLY 3087. DESPITE MULTIPLE REMINDERS, NO RESPONSE HAS BEEN RECEIVED REGARDING THE CORRECTIVE ACTIONS TAKEN ON THE DEVICE. ADDITIONALLY, NO SPECIFIC TECHNICAL FAULT OR FAILURE DESCRIPTION HAS BEEN PROVIDED¿ONLY THE STATEMENT THAT "THE DEVICE SHUT DOWN WITH THE PATIENT." IT WAS NOTED, HOWEVER, THAT NO HARM TO THE PATIENT WAS REPORTED. BASED ON THE AVAILABLE DATA, THE EXACT ROOT CAUSE OF THE ISSUE CANNOT BE DETERMINED. LOG FILE ANALYSIS SUGGESTS THAT A POWER SUPPLY ISSUE OR BATTERY BACKUP FAILURE MAY HAVE CONTRIBUTED TO THE EVENT; HOWEVER, AS IT WAS MENTIONED ABOVE, THE EXACT ROOT CAUSE REMAINS UNKNOWN.

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: QUOTATION FROM THE REPORTER: "RT SAW ID2, MACHINE SHUT OFF." THE OCCURRENCE WAS DURING THE VENTILATION. ADDITIONAL INFORMATION WAS RECEIVED: NO HARM TO THE PATIENT OCCURRED AND NO MEDICAL INTERVENTION WAS NECESSARY. ADDITIONALLY, THE MANUFACTURER WAS INFORMED THAT THE USER DID NOT REPORTED THIS EVENT TO THE LOCAL AUTHORITIES.

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: QUOTATION FROM THE REPORTER: "RT SAW ID2, MACHINE SHUT OFF." ACCORDING TO THE COMPLAINT DESCRIPTION, THE EVENT OCCURRED DURING VENTILATION, RESULTING IN PATIENT HARM. HOWEVER, NO FURTHER DETAILS WERE PROVIDED. ADDITIONALLY, A MEDICAL INTERVENTION WAS NECESSARY, BUT THE SPECIFIC TYPE OF INTERVENTION REQUIRED WAS NOT SPECIFIED. MOREOVER, THE MANUFACTURER WAS INFORMED THAT THE USER REPORTED THIS EVENT TO LOCAL AUTHORITIES, ALTHOUGH NO REFERENCE NUMBER WAS PROVIDED. FURTHER INQUIRIES HAVE BEEN SENT TO THE CUSTOMER TO OBTAIN ADDITIONAL DETAILS ABOUT THE EVENT.

    Description of Event or Problem · 0

    THE MANUFACTURER HAS RECEIVED A NEW EVENT DESCRIPTION WHERE IT STATED ONLY THAT "THE DEVICE SHUT DOWN WITH THE PATIENT", BUT NO SPECIFIC TECHNICAL FAULT OR FAILURE DESCRIPTION WAS PROVIDED. NO HARM TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1146799 HAMILTON G5 HAMILTON G5 CBK HAMILTON MEDICAL AG 159002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other