BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-G5

    MDR report key: 18010889 · Received October 26, 2023

    Report

    Report Number
    3001421318-2023-03668
    Event Type
    Malfunction
    Date Received
    October 26, 2023
    Date of Event
    October 5, 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
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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 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: **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.

    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.

    Description of Event or Problem · 0

    REPORT FROM USER IS AS FOLLOWS "ONE OF THE S1'S HAS BEEN GIVING THE WRONG INFORMATION. IT HAD A HUMIDIFIED CIRCUIT IN AND HAS BEEN RUNNING OK FOR THE LAST FEW DAYS. OVER NIGHT, STAFF HAVE REPORTED THE RESPIRATORY RATE WAS REORDERING AT >80BPM AND THE VT HAD OBSCURE READINGS.".

    Description of Event or Problem · 0

    REPORT FROM USER IS AS FOLLOWS "ONE OF THE S1'S HAS BEEN GIVING THE WRONG INFORMATION. IT HAD A HUMIDIFIED CIRCUIT IN AND HAS BEEN RUNNING OK FOR THE LAST FEW DAYS. OVER NIGHT, STAFF HAVE REPORTED THE RESPIRATORY RATE WAS REORDERING AT >80BPM AND THE VT HAD OBSCURE READINGS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1674006 HAMILTON-G5 HAMILTON-G5 VENTILATOR CBK HAMILTON MEDICAL AG 159001 07630002800013

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown