BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-C1

    MDR report key: 21907279 · Received April 25, 2025

    Report

    Report Number
    3001421318-2025-00560
    Event Type
    Malfunction
    Date Received
    April 25, 2025
    Date of Event
    April 10, 2025
    Report Date
    February 18, 2026
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002800747
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG REF NR: (B)(4).

    Additional Manufacturer Narrative · 0

    INVESTIGATION OUTCOME: COMPLAINT DESCRIPTION: WHEN HOSPITAL STAFF WERE USING THIS C1 ON A PATIENT, TECHNICAL EVENT: 232005 APPEARED ON THE SCREEN, AN ALARM SOUNDED, AND IT SWITCHED TO AMBIENT MODE, SO THEY REPLACED IT WITH ANOTHER VENTILATOR. NO HEALTH CONSEQUENCES OR IMPACT. THE HAMILTON C1 WAS CHECKED BY THE TECHNICIAN ON SITE. A STRANGE NOISE COULD BE HEARD COMING FROM THE FAN AND THE FAN WAS IDENTIFIED THE SOURCE OF THE ISSUE. THIS CASE IS CONSIDERED AS CLOSED.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: "WHEN HOSPITAL STAFF WERE USING THIS C1 ON A PATIENT, TECHNICAL EVENT: 232005 APPEARED ON THE SCREEN, AN ALARM SOUNDED, AND IT SWITCHED TO AMBIENT MODE, SO THEY REPLACED IT WITH ANOTHER VENTILATOR." THE PATIENT WAS NOT HARMED, AND NO CONSEQUENCES OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1227428 HAMILTON-C1 HAMILTON-C1 CBK HAMILTON MEDICAL AG 161001 07630002800747

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown