BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-C3

    MDR report key: 20542767 · Received October 28, 2024

    Report

    Report Number
    3001421318-2024-02588
    Event Type
    Malfunction
    Date Received
    October 28, 2024
    Date of Event
    October 16, 2024
    Report Date
    January 21, 2025
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002801881
    PMA / PMN Number
    K201306
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMES TO THE CONCLUSION: INVESTIGATION ONGOING. A DETAILED INVESTIGATION WAS PERFORMED BY AN EXPERT FROM THE TECHNICAL SERVICE: THE ROOT CAUSE WAS DETERMINED TO BE A LOSE CONNECTION OF THE FFCABLE (PART N° 160355) OF THE PRESSURE SENSOR ASSEMBLY (PSA). DURING REGULAR USE VIBRATIONS CAUSED BY MOVEMENTS AND TRANSPORT OF THE DEVICE CAN LEAD TO A LOSE FFCABLE CONNECTION BETWEEN THE PSA AND THE MAINBOARD. THE LOGFILE ANALYSIS CONFIRMED THE OCCURRENCE OF TECHNICAL FAILURES TF 341009, TF 346054 AND TE 231036. THESE TFS ARE TYPICAL FOR A FAILURE OF THE PVENT CONTROL PRESSURE SENSOR, WHICH MEASURES THE PRESSURE AT THE PATIENT OUT-LET. THE CORRECTION CONSISTED IN THE CONTROL AND REFIXATION OF THE FFCABLE OF THE PRESSURE SENSOR ASSEMBLY. IN THIS CASE THE DEVICE SWITCHED INTO SAFETY MODE DURING SUCTION. WHEN A DEVICE RUNS IN SAFETY MODE THE VENTILATION CONTINUES BUT CERTAIN SPECIFIC VENTILATION MODES ARE NOT AVAILABLE ANYMORE. THEREFORE, THE USER HAD TO SWITCH THE DEVICE. THE EXCHANGE OF A VENTILATOR IS A ROUTINE PROCEDURE BUT IN A WORST-CASE SCENARIO A DETERIORATION OF THE STATE OF HEALTH OF THE PATIENT CANNOT BE EXCLUDED. THIS IS WHY THIS CASE WAS ASSESSED REPORTABLE. THIS INCIDENT OCCURRED DURING VENTILATION WHILE A PATIENT WAS CONNECTED TO THE DEVICE. THE DEVICE HAD TO BE EXCHANGED BUT THERE WAS NO PATIENT OR USER HARM.

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMES TO THE CONCLUSION: INVESTIGATION ONGOING.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY: AN ERROR OCCURRED DURING SUCTION; THE DEVICE HAS ENTERED 'SAFETY VENTILATION' MODE.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY: AN ERROR OCCURRED DURING SUCTION; THE DEVICE HAS ENTERED 'SAFETY VENTILATION' MODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1019776 HAMILTON-C3 HAMILTON-C3 CBK HAMILTON MEDICAL AG 160005 07630002801881

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown