BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 15456295 · Received September 20, 2022

    Report

    Report Number
    3001421318-2022-00015
    Event Type
    Malfunction
    Date Received
    September 20, 2022
    Date of Event
    August 3, 2022
    Report Date
    September 20, 2022
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    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 FUNCTION, AND HAVE THE SAME DEVICE CLASSIFICATION AND PRODUCT CODE UNDER 21 CFR 868.5895. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HMAG RECEIVED THE LOG FILES FROM THE VENTILATOR AND THEY WERE ANALYZED. THE USER IS NOT SURE ABOUT THE TIME OF THE INCIDENT. ACCORDING TO THE LOG FILES, THE REAL INCIDENT TIME IS (B)(6) 2022.VENTILATOR UNIT CONNECTION LOST OCCURRED ON (B)(6) 2022 AND VENTILATION DID NOT STOP. THE ROOT CAUSE IS THE COMMUNICATION PROBLEM BETWEEN VENTILATOR UNIT (VU) AND INTERACTION PANEL (IP). REPLACEMENT OF COMMUNICATION CABLE VU IP WAS SUGGESTED. HAMILTON MEDICAL AG CASE REFERENCE NR: (B)(4).

    Description of Event or Problem · 0

    HMAG RECEIVED THE FOLLOWING EVENT DESCRIPTION: "WHILE TRANSPORTING THE PATIENT TO THE FACILITY (TO PERFORM A COMPUTED TOMOGRAPHY SCAN), THE WHITE SCREEN VENTILATOR TURNED OFF WITHOUT TRIGGERING AN ALARM. THE S1 VENTILATOR WAS SET ASIDE AND ANALYZED BY BIOMEDICAL MAINTENANCE. IN THEIR OPINION, IT WAS A PROBLEM WITH THE RJ45 CABLE DISCONNECTION BETWEEN THE SCREEN AND THE VENTILATOR. PRODUCT NAME : VENTILATOR HAMILTON S1. SERIAL NO. (B)(4). A REPORT WILL BE MADE TO SWISSMEDIC (IT IS A SERIOUS INCIDENT, BUT WITHOUT HARM TO THE PATIENT WHO WAS VENTILATED WITH THE BALLOON DURING THE TIME BETWEEN THE VENTILATOR CHANGE)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2551214 HAMILTON MEDICAL AG HAMILTON-S1 CBK HAMILTON MEDICAL AG HAMILTON-S1

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown