BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-G5

    MDR report key: 17867929 · Received October 4, 2023

    Report

    Report Number
    3001421318-2023-03452
    Event Type
    Malfunction
    Date Received
    October 4, 2023
    Date of Event
    September 26, 2023
    Report Date
    October 14, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002800013
    PMA / PMN Number
    K193228
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    QA
    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 FUNCTION, AND HAVE THE SAME DEVICE CLASSIFICATION AND PRODUCT CODE UNDER 21 CFR 868.5895. ALARM LAMP DOES NOT WORK. AFFECTED COMPONENT IS THE ALARM LAMP BOARD. ALARM LAMP BOARD WILL BE REPLACED.

    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. ALARM LAMP DOES NOT WORK. AFFECTED COMPONENT IS THE ALARM LAMP BOARD. ALARM LAMP BOARD WILL BE REPLACED. HAMILTON MEDICAL AG COMPLAINT NUMBER: CER (B)(4). FOLLOW-UP 1 - CORRECTED INFORMATION: UDI RELATED DATA QUALITY UPDATES ONLY 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.

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION: WHILE PREVENTIVE MAINTENANCE, THE RED LIGHT WAS NOT WORKING DURING THE LED TEST.

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION: WHILE PREVENTIVE MAINTENANCE, THE RED LIGHT WAS NOT WORKING DURING THE LED TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1526305 HAMILTON-G5 HAMILTON-G5 VENTILATOR CBK HAMILTON MEDICAL AG 159001 07630002800013

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown