BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-C6

    MDR report key: 21092055 · Received January 7, 2025

    Report

    Report Number
    3001421318-2025-00028
    Event Type
    Malfunction
    Date Received
    January 7, 2025
    Date of Event
    December 18, 2024
    Report Date
    November 16, 2025
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002808590
    PMA / PMN Number
    K201658
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMES TO THE CONCLUSION: INVESTIGATION ONGOING.

    Additional Manufacturer Narrative · 0

    FOLLOW-UP 1 (FINAL) - ADDITIONAL INFORMATION: THE ENTRY FIELDS B4, G6, H2, H3, H6 AND H11 HAVE BEEN UPDATED. THE FOLLOWING WAS REPORTED: IT SOUNDS LIKE THE SCREEN WAS NOT WORKING PRIOR TO PLACING THE PATIENT ON THE VENT". THE PROBLEM OF THE TOUCHSCREEN NOT WORKING OCCURRED DURING SYSTEM STARTUP, PRIOR TO PLACING THE PATIENT ON THE VENTILATOR. DUE TO THE FACT THAT THE VENTILATOR WAS STILL OPERATIONAL WITH THE USE OF P&T KNOB, THE RESPIRATORY THERAPIST DECIDED NOT TO TAKE THE DEVICE OUT OF USE IMMEDIATELY AFTER THE ISSUE WAS NOTICED AND CONTINUED TO USE THE VENTILATOR WITH A PATIENT FOR NEARLY 6,5H HOURS. NEITHER HARM TO PATIENT, USER OR THIRD PARTY NOR A TREATMENT DELAY WAS REPORTED. THE VENTILATOR WAS REPLACED AFTER FINISHING THE VENTILATION OF THE LATEST PATIENT. AS PER LOGFILE INVESTIGATION, ON THE DATE OF THE EVENT, 18.12.2024, THE DEVICE WAS POWERED ON 11:58:26. WHILE REVIEWING THE ERROR LOG, AN IDENTICAL SCENARIO AS IN THE CASE DESCRIBED IN TASKM-4603 OCCURRED - THE SELF-TEST TOUCH CONTROLLER FAILED, AND THE MXT INFOBLOCK CRC TEST FAILED. A DEVICE WITH THE ISSUE IN SCOPE CAN STILL BE OPERATED USING THE P&T KNOB, AND THE DEVICE WAS CONTINUED TO BE USED UNTIL 18:20:03. THE NEXT STARTUP TOOK PLACE AT 18:30:03 AND THE ISSUE DID NOT OCCUR AGAIN AFTER INFOBLOCK CRC FAIL DETECTION AND AUTO-RESET OF THE TOUCH CONTROLLER ELECTRONICS WHICH HAPPENED DURING THE NEXT STARTUP. AT THE END, CAUSE LINKED TO DEVICE BUT UNABLE TO TRACE MORE.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: DETAILED COMPLAINT AND FAILURE DESCRIPTION: (1) "AS YOU ARE LIKELY AWARE, TODAY AT ORMC ONE OF THE NEW HAMILTON C6 VENTS THAT WAS PUT ON A PATIENT HAD SCREEN ISSUES. IT SOUNDS LIKE THE SCREEN WAS NOT WORKING PRIOR TO PLACING THE PATIENT ON THE VENT. I AM UNSURE WHY THE THERAPIST CONTINUED WITH THE PROCESS BUT THAT IS A SEPARATE ISSUE. I BELIEVE I DOWNLOADED THE FILES CORRECTLY FROM THE SERVICE SOFTWARE MODE. I HAVE ATTACHED THE DATA THAT I COLLECTED. PLEASE LET ME KNOW IF THIS IS CORRECT SO I AM AWARE OF HOW TO GATHER THE INFORMATION YOU WILL NEED TO ASSIST WITH FUTURE SERVICE ISSUES." HEALTH IMPACT: (2) ADDITIONAL DEVICE WAS REQUIRED. NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS, REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1012088 HAMILTON-C6 HAMILTON-C6 CBK HAMILTON MEDICAL AG 160021 07630002808590

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown