BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-G5

    MDR report key: 18730808 · Received February 19, 2024

    Report

    Report Number
    3001421318-2024-00396
    Event Type
    Malfunction
    Date Received
    February 19, 2024
    Date of Event
    January 31, 2024
    Report Date
    November 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
    AZ, US
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS ONGOING. HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4). FOLLOW-UP 1 - CORRECTED INFORMATION: **UDI RELATED DATA QUALITY UPDATES ONLY** FIELD D4 WAS UPDATED WITH FULL UDI INFORMATION. UPDATED FIELDS: B4, D4, G6, H2, H4, H11.

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION: VENTILATOR INITIATED APPROX. 01/30 @ 2000. EVENTS: NOC EVENTS: INCREASED PEAK PRESSURES. WITH NO SECRETIONS & NO WHEEZES, EXTRA CONDENSATION DUMPED FROM EXPIRATORY LIMB, DIAPHRAGM AND FILTERS CHANGED BY NOC RT BEFORE DAYSHIFT. ON THE DAY SHIFT 01/31 EXPIRATORY LIMB RETAINING LARGE AMOUNT OF CONDENSATION FILLING UP APPROX. 40% OF CIRCUIT, DAY RT DUMPED OUT 3 TIMES BEFORE 1100, THE 4TH TIME RN CALL SAYING THE VENT WAS ALARMING HIGH PEEP, OBSTRUCTION ON EXHALATION BLOCKED. THE PIN WAS CLEANED HOWEVER THE VENT WAS NOT RETURNING TO BASELINE.

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION: VENTILATOR INITIATED APPROX. 01/30 @ 2000. EVENTS: NOC EVENTS: INCREASED PEAK PRESSURES. WITH NO SECRETIONS & NO WHEEZES, EXTRA CONDENSATION DUMPED FROM EXPIRATORY LIMB, DIAPHRAGM AND FILTERS CHANGED BY NOC RT BEFORE DAYSHIFT. ON THE DAY SHIFT 01/31 EXPIRATORY LIMB RETAINING LARGE AMOUNT OF CONDENSATION FILLING UP APPROX. 40% OF CIRCUIT, DAY RT DUMPED OUT 3 TIMES BEFORE 1100, THE 4TH TIME RN CALL SAYING THE VENT WAS ALARMING HIGH PEEP, OBSTRUCTION ON EXHALATION BLOCKED. THE PIN WAS CLEANED HOWEVER THE VENT WAS NOT RETURNING TO BASELINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541443 HAMILTON-G5 HAMILTON-G5 VENTILATOR CBK HAMILTON MEDICAL AG 159002 07630002802208

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown