BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON G5

    MDR report key: 21749715 · Received April 2, 2025

    Report

    Report Number
    3001421318-2025-00477
    Event Type
    Malfunction
    Date Received
    April 2, 2025
    Date of Event
    February 3, 2025
    Report Date
    December 16, 2025
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002802208
    PMA / PMN Number
    K193228
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4). INVESTIGATION ONGOING.

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4). FOLLOW-UP 1: INVESTIGATION OUTCOME. 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 LOGFILE ANALYSIS, LOSS OF MAIN POWER WAS RECORDED. LINE 185: 2025-02-03 15:44:29 LOSS OF MAINS POWER SUPPLY 3087. LINE 258: 2025-02-03 15:40:35 LOSS OF MAINS POWER SUPPLY 3087. LINE 280: 2025-02-03 08:50:04 LOSS OF MAINS POWER SUPPLY 3087. LINE 341: 2025-02-03 08:39:03 LOSS OF MAINS POWER SUPPLY 3087. LINE 2162: 2025-02-01 15:44:04 LOSS OF MAINS POWER SUPPLY 3087. A TECHNICAL INSPECTION OF THE DEVICE WAS PERFORMED, DURING WHICH THE CONNECTION BETWEEN THE VU AND IP CABLES WAS VERIFIED. ELECTRICAL SAFETY TESTS WERE COMPLETED WITH NO DEVIATIONS. THE DEVICE WAS OPERATED IN VENTILATION MODE, AND REMOVAL OF AC POWER DID NOT PRODUCE ANY ABNORMAL BEHAVIOR. THE PREVENTIVE MAINTENANCE (PM) KIT WAS INSTALLED, FOLLOWED BY SERVICE SOFTWARE TESTING AND FULL OPERATIONAL TESTING. ALL TESTS WERE SUCCESSFULLY COMPLETED. THE UNIT WAS APPROVED FOR RETURN TO SERVICE ON 14 MARCH 2025.

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: DURING A POWER OUTAGE AT THE HOSPITAL, THE BACKUP GENERATOR WAS ACTIVATED. IN THE NICU, SAFETY CHECKS WERE PROMPTLY CONDUCTED ON PATIENTS REQUIRING VENTILATOR SUPPORT. IN ONE ROOM, A PATIENT'S VENTILATOR SCREEN WENT BLANK, THEREFORE, THE PATIENT WAS MANUALLY BAGGED UNTIL THE DEVICE RESUMED OPERATION. IT WAS UNCLEAR IF THE VENTILATOR STOPPED PROVIDING ACTUAL PRESSURE TO THE PATIENT OR IF IT WAS JUST THE SCREEN THAT HAD GONE BLANK. THE PATIENT WAS SUBSEQUENTLY TRANSFERRED TO A DIFFERENT VENTILATOR. NO HARM WAS REPORTED, AND MANUAL VENTILATION WAS GIVEN, JUST IN CASE THE VENT WAS NOT WORKING¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2698406 HAMILTON G5 HAMILTON G5 CBK HAMILTON MEDICAL AG 159002 07630002802208

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown