BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 17152177 · Received June 19, 2023

    Report

    Report Number
    3001421318-2023-02412
    Event Type
    Malfunction
    Date Received
    June 19, 2023
    Date of Event
    October 18, 2023
    Report Date
    April 9, 2025
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION ADDED IN FOLLOW-UP #1 (B)(4). THE ISSUE WAS DISCOVERED DURING START UP WITH NO PATIENT INVOLVED. CONSEQUENTLY, THE EVENT DID NOT CAUSE OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY. THE ROOT CAUSE OF THE EVENT WAS DETERMINED TO BE A DEFECTIVE ESM BOARD. AFTER REPLACING THE ESM BOARD AND CALIBRATION OF THE DEVICE IT WAS FOUND TO BE FUNCTIONAL AND WAS RELEASED FOR USE. THE ISSUE IS CONSIDERED A REPORTABLE EVENT BECAUSE IT COULD POTENTIALLY IMPACT PATIENT SAFETY DURING VENTILATION SINCE THE DEFECT ON THE ESM BOARD COULD RESULT IN INADEQUATE VENTILATION SUPPORT. IN AGREEMENT WITH THE FDA, UDI NUMBERS (FIELD D4 IN THIS FORM) ARE ONLY PROVIDED FOR INCIDENTS THAT HAVE BEEN INITIALLY REPORTED BY HAMILTON MEDICAL AG SINCE OCTOBER 1ST, 2023.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORT, THIS IS A CASE REPORT RECEIVED ON JUNE 10TH FROM HAMILTON MEDICAL INC. RELATED TO TECHNICAL FAULT OBSERVED ON A (B)(6) 2022 ON A HAMILTON C1 VENTILATOR (SN# (B)(6), SOFTWARE VERSION 2.2.10). ACCORDING TO THE REPORTER, THERE IS NO PATIENT INVOLVED. THE ISSUE DID NOT OCCURRED DURIGN VENTILATION. PRELIMINARY ANALYSIS REVEALED THAT: IN THE CONFIGURATION MENU THE OPTIONS DISAPPEARED. OPTIONS ARE NO LONGER AVAILABLE. IN THE CONFIGURATION MENU THERE ARE NO OPTIONS DISPLAYED IN "SW OPTIONS". 'REALTIME CLOCK FAILURE' MIGHT BE DISPLAYED AS WELL. OR OPTION KEYS ARE NOT VISIBLE / AVAILABLE ANYMORE. VENTILATION CANNOT START. POTENTIAL ROOT CAUSE IS RELATED TO THE RESET OF THE REALTIME CLOCK (RTC) DUE TO LOSS OF SUPPLY VOLTAGE FOR LONGER THAN APPROX. ONE WEEK ESM BOARD NOT PROPERLY CONNECTED. AS IMMEDIATE CORRECTION, THE FOLLOWING ACTION HAVE BEEN PERFORMED: SET CORRECT REAL TIME CLOCK (RTC) IN SERVICE SOFTWARE PAGE 1401 AND RESTART THE UNIT. INSTALL THE LATEST SOFTWARE VERSION. ENTER THE ADULT ACTIVATION CODE AND RESTART THE UNIT. IF FAILURE PERSISTS ALSO CHECK THE ESM BOARD FOR PROPER CONNECTION TO THE MAINBOARD.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORT, THIS IS A CASE REPORT RECEIVED ON JUNE 10TH FROM HAMILTON MEDICAL INC. RELATED TO TECHNICAL FAULT OBSERVED ON OCTOBER 18TH 2022 ON A HAMILTON C1 VENTILATOR (SN# (B)(6), SOFTWARE VERSION 2.2.10) ACCORDING TO THE REPORTER, THERE IS NO PATIENT INVOLVED. THE ISSUE DID NOT OCCURRED DURIGN VENTILATION. PRELIMINARY ANALYSIS REVEALED THAT: IN THE CONFIGURATION MENU THE OPTIONS DISAPPEARED. - OPTIONS ARE NO LONGER AVAILABLE. IN THE CONFIGURATION MENU THERE ARE NO OPTIONS DISPLAYED IN "SW OPTIONS". 'REALTIME CLOCK FAILURE' MIGHT BE DISPLAYED AS WELL. OR OPTION KEYS ARE NOT VISIBLE / AVAILABLE ANYMORE. VENTILATION CANNOT START. POTENTIAL ROOT CAUSE IS RELATED TO THE RESET OF THE REALTIME CLOCK (RTC) DUE TO LOSS OF SUPPLY VOLTAGE FOR LONGER THAN APPROX. ONE WEEK ESM BOARD NOT PROPERLY CONNECTED. AS IMMEDIATE CORRECTION, THE FOLLOWING ACTION HAVE BEEN PERFORMED: SET CORRECT REAL TIME CLOCK (RTC) IN SERVICE SOFTWARE PAGE 1401 AND RESTART THE UNIT INSTALL THE LATEST SOFTWARE VERSION. ENTER THE ADULT ACTIVATION CODE AND RESTART THE UNIT IF FAILURE PERSISTS ALSO CHECK THE ESM BOARD FOR PROPER CONNECTION TO THE MAINBOARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778127 HAMILTON MEDICAL AG HAMILTON-C1 CBK HAMILTON MEDICAL AG HAMILTON-C1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown