BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-G5

    MDR report key: 18660349 · Received February 7, 2024

    Report

    Report Number
    3001421318-2024-00307
    Event Type
    Malfunction
    Date Received
    February 7, 2024
    Date of Event
    January 29, 2024
    Report Date
    November 5, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002800013
    PMA / PMN Number
    K193228
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    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: FIELD D4 WAS UPDATED WITH FULL UDI INFORMATION. PLEASE NOTE THAT THE PREVIOUS NARRATIVE ABOVE NEEDS TO BE CORRECTED: THE DEVICE IN QUESTION WAS A HAMILTON-G5 (K193228, BRAND NAME: HAMILTON-G5; VERSION / MODEL / CATALOG NUMBER: 159001) WHICH WAS DISTRIBUTED IN THE UNITED STATES. CORRESPONDING FIELDS WERE UPDATED. UPDATED FIELDS: B4, D1, D2A, D4, G4, G6, H2, H4, H11.

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION: I WOULD LIKE AN INTERVENTION ON OUR G5 "BIO6843" S/N 1750 VENTILATOR, LOCATED IN INTENSIVE CARE. PROBLEM NOTED: "O2 100%" BUTTON MALFUNCTIONS, TAKES A LONG TIME TO ACTIVATE.

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION: I WOULD LIKE AN INTERVENTION ON OUR G5 "BIO6843" S/N (B)(6) VENTILATOR, LOCATED IN INTENSIVE CARE. PROBLEM NOTED: "O2 100%" BUTTON MALFUNCTIONS, TAKES A LONG TIME TO ACTIVATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1763790 HAMILTON-G5 HAMILTON-G5 VENTILATOR CBK HAMILTON MEDICAL AG 159001 07630002800013

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown