BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-S1

    MDR report key: 18053515 · Received November 2, 2023

    Report

    Report Number
    3001421318-2023-03708
    Event Type
    Malfunction
    Date Received
    November 2, 2023
    Date of Event
    October 20, 2023
    Report Date
    November 22, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    PMA / PMN Number
    K193228
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    505

    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.

    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. HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4). FOLLOW-UP 1 - CORRECTED INFORMATION: WITHIN THE UDI-PI PROJECT, HAMILTON MEDICAL REALIZED THAT THE REPORTED DEVICE (BRAND NAME: HAMILTON-S1; VERSION / MODEL / CATALOG NUMBER: 159005) IN THE PRESENT MDR IS NOT FULFILLING THE CRITERIA OF SIMILARITY FOR A DEVICE MARKETED IN THE U.S., THEREFORE THIS EVENT IS NO LONGER CONSIDERED REPORTABLE TO FDA AND NO UDI-PI IS GOING TO BE PROVIDED.

    Description of Event or Problem · 0

    DURING VENTILATION, THE SCREEN TURNED BLUE AND STARTED TO ALARM.

    Description of Event or Problem · 0

    DURING VENTILATION, THE SCREEN TURNED BLUE AND STARTED TO ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1889340 HAMILTON-S1 HAMILTON-S1 VENTILATOR CBK HAMILTON MEDICAL AG

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown