BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-G5

    MDR report key: 18989055 · Received March 27, 2024

    Report

    Report Number
    3001421318-2024-00746
    Event Type
    Malfunction
    Date Received
    March 27, 2024
    Date of Event
    January 29, 2024
    Report Date
    November 20, 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

    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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION: THE DEVICE IS FAILING TEST 8 OF THE PM; IT IS TAKING ABOUT 5 SECONDS FOR PTANK TO DROP FROM 300 TO 280. I''VE CHECKED MULTIPLE TUBES/O-RINGS/CONNECTIONS BUT STILL CAN''T FIND THE ISSUE. THIS OCCURRED DURING PM. UPGRADED THE SOFTWARE FROM 281B TO 2.90E. REPLACED MIXER VALVES, PRESSURE RELEASE VALVE, PRESSURE SENSE BOARD AND PRESSURE REGULATOR. THE PTANK PRESSURE STILL DROPS FROM 300 TO 280 IN LES THAN EIGHT SECONDS. THE NEXT STEP WILL BE TO REPLACE THE MOTHER BOARD. THIS CASE WILL BE UPDATED ONE THE REPAIRS ARE COMPLETED.

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION: THE DEVICE IS FAILING TEST 8 OF THE PM; IT IS TAKING ABOUT 5 SECONDS FOR PTANK TO DROP FROM 300 TO 280. I''VE CHECKED MULTIPLE TUBES/O-RINGS/CONNECTIONS BUT STILL CAN''T FIND THE ISSUE. THIS OCCURRED DURING PM. UPGRADED THE SOFTWARE FROM 281B TO 2.90E. REPLACED MIXER VALVES, PRESSURE RELEASE VALVE, PRESSURE SENSE BOARD AND PRESSURE REGULATOR. THE PTANK PRESSURE STILL DROPS FROM 300 TO 280 IN LES THAN EIGHT SECONDS. THE NEXT STEP WILL BE TO REPLACE THE MOTHER BOARD. THIS CASE WILL BE UPDATED ONE THE REPAIRS ARE COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1928300 HAMILTON-G5 HAMILTON-G5 VENTILATOR CBK HAMILTON MEDICAL AG 159002 07630002802208

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown