BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-C1

    MDR report key: 19236329 · Received May 3, 2024

    Report

    Report Number
    3001421318-2024-01082
    Event Type
    Malfunction
    Date Received
    May 3, 2024
    Date of Event
    April 19, 2024
    Report Date
    October 23, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002800747
    PMA / PMN Number
    K181216
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG CASE NUMBER IS: (B)(4). FIRST ASSESSMENT OF THE CASE: ON REVIEWING THE LOGS IT WAS OBSERVED THAT THE DEVICE REPEATEDLY ALARMED FOR 'VT LOW', 'LOW MINUTE VOLUME' AND 'MAXIMUM LEAK COMPENSATION' DURING VENTILATION IN (S) CMV+ MODE. IT ALSO SPORADICALLY ALARMED FOR 'INSPIRATORY VOLUME LIMITATION' AND 'DISCONNECTION ON PATIENT SIDE'. NO PRE-OPP CHECK WAS PERFORMED BEFORE THE DEVICE WAS USED ON THE REPORTED DATED OF INCIDENT. NO TF/TE APPEARED IN DEVICE LOGS.

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG CASE NUMBER IS: CER (B)(4). FIRST ASSESSMENT OF THE CASE: ON REVIEWING THE LOGS IT WAS OBSERVED THAT THE DEVICE REPEATEDLY ALARMED FOR 'VT LOW', 'LOW MINUTE VOLUME' AND 'MAXIMUM LEAK COMPENSATION' DURING VENTILATION IN (S) CMV+ MODE. IT ALSO SPORADICALLY ALARMED FOR 'INSPIRATORY VOLUME LIMITATION' AND 'DISCONNECTION ON PATIENT SIDE'. NO PRE-OPP CHECK WAS PERFORMED BEFORE THE DEVICE WAS USED ON THE REPORTED DATED OF INCIDENT. NO TF/TE APPEARED IN DEVICE LOGS FOLLOW-UP 1 - CORRECTED INFORMATION: **UDI RELATED DATA QUALITY UPDATES ONLY** FIELD D4 WAS UPDATED WITH FULL UDI INFORMATION.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: "DURING A PROCEDURE, THE VENTILATOR BEGAN ALARMING AND THE PATIENT DECOMPENSATED. THE PRESSURE WAVEFORM REMAINED INTACT BUT THE FLOW AND VOLUME WAVEFORM BECAME FLAT. THE PATIENT WAS MANUALLY VENTILATED UNTIL THEY RECOVERED AND CONNECTED BACK ONTO THE VENTILATOR. THE SAME ISSUE HAPPENED AND THE PATIENT WAS MANUALLY VENTILATED BACK TO THE UNIT." NOTE: CIRCUIT THAT HAS BEEN USED IS MRI PATIENT CIRCUIT, PRE-USE TEST HAS NOT BEEN DONE PRIOR USE. PATIENT RECOVERED.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: "DURING A PROCEDURE, THE VENTILATOR BEGAN ALARMING AND THE PATIENT DECOMPENSATED. THE PRESSURE WAVEFORM REMAINED INTACT BUT THE FLOW AND VOLUME WAVEFORM BECAME FLAT. THE PATIENT WAS MANUALLY VENTILATED UNTIL THEY RECOVERED AND CONNECTED BACK ONTO THE VENTILATOR. THE SAME ISSUE HAPPENED AND THE PATIENT WAS MANUALLY VENTILATED BACK TO THE UNIT." NOTE: CIRCUIT THAT HAS BEEN USED IS MRI PATIENT CIRCUIT, PRE-USE TEST HAS NOT BEEN DONE PRIOR USE. PATIENT RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1421243 HAMILTON-C1 HAMILTON-C1 CBK HAMILTON MEDICAL AG 161001 07630002800747

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention