BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-C1

    MDR report key: 21010165 · Received December 24, 2024

    Report

    Report Number
    3001421318-2024-03002
    Event Type
    Malfunction
    Date Received
    December 24, 2024
    Date of Event
    November 3, 2024
    Report Date
    November 21, 2025
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG CASE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: THE FACILITY REPORTED WHILE USING NPCAP MODE ON A PATIENT THE VENTILATOR ALARMED WITH TECHNICAL EVENT (AUTOZERO ERROR QAW/PAW). THEY REPORTED THIS OCCURRED NUMEROUS TIMES: (B)(6) 2024 AND (B)(6) 2024. THE VENTILATOR WAS REMOVED FROM USE AND REPLACED WITH ANOTHER VENTILATOR. NO HEALTH CONSEQUENCES OR IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2364507 HAMILTON-C1 HAMILTON-C1 CBK HAMILTON MEDICAL AG 161001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown