BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-S1

    MDR report key: 16805125 · Received April 25, 2023

    Report

    Report Number
    3001421318-2023-01561
    Event Type
    Malfunction
    Date Received
    April 25, 2023
    Date of Event
    March 27, 2023
    Report Date
    April 25, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE HAMILTON-S1 IS NOT DISTRIBUTED IN THE UNITED STATES; HOWEVER, HAMILTON MEDICAL AG CONSIDERS THE HAMILTON-S1 SIMILAR TO THE HAMILTON-G5 (K193228) IN THAT THE TWO VENTILATORS HAVE BASIC DESIGN AND PERFORMANCE CHARACTERISTICS RELATED TO DEVICE SAFETY AND EFFECTIVENESS, HAVE THE SAME INTENDED USE AND FUCTION, AND HAVE THE SAME DEVICE CLASSIFICATION AND PRODUCT CODE UNDER 21 CFR 868.5895. INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG (HMAG) RECEIVED THE FOLLOWING INCIDENT DESCRIPTION: "PANEL CONNECTION LOST."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1336176 HAMILTON-S1 HAMILTON-S1 VENTILATOR CBK HAMILTON MEDICAL AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown