BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-G5

    MDR report key: 19017566 · Received April 2, 2024

    Report

    Report Number
    3001421318-2024-00785
    Event Type
    Malfunction
    Date Received
    April 2, 2024
    Date of Event
    February 28, 2024
    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
    AU
    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: CER (B)(4). FOLLOW-UP 1 - CORRECTED INFORMATION: UDI RELATED DATA QUALITY UPDATES ONLY 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. CREATION OF UDI WAS NOT A REQUIREMENT AT THE TIME OF MANUFACTURING OF THIS PARTICULAR DEVICE WITH THE SERIAL NUMBER (B)(6) (PRIOR TO 2015) AND HAD NOT YET BEEN IMPLEMENTED IN PRODUCTION. AN UDI (INCLUDING UDI-PI) WILL THEREFORE NOT BE PROVIDED, THIS IS IN ALIGNMENT WITH THE INFORMATION ON THE LABEL ON THE DEVICE WITH THE SERIAL NUMBER(B)(6). UPDATED FIELDS.

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION: NEW O2 CELL CANNOT BE CALIBRATED, O2 MAX. 3.2 V. REF (B)(4). BATCH 07082023. EXP 2026-08-07. NEW O2 CELL WAS INSTALLED.

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION: NEW O2 CELL CANNOT BE CALIBRATED, O2 MAX. 3.2 V REF 396009/00, BATCH 07082023, EXP 2026-08-07, NEW O2 CELL WAS INSTALLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1051468 HAMILTON-G5 HAMILTON-G5 VENTILATOR CBK HAMILTON MEDICAL AG 159001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown