BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-C3

    MDR report key: 19601463 · Received June 24, 2024

    Report

    Report Number
    3001421318-2024-01425
    Event Type
    Malfunction
    Date Received
    June 24, 2024
    Date of Event
    May 30, 2024
    Report Date
    October 16, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002801881
    PMA / PMN Number
    K201306
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMPLAINT NUMBER: CER (B)(6). 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 HAS BEEN REPORTED TO HAMILTON MEDICAL AG ON 19 JUNE 2024 IT WAS REPORTED THAT ON (B)(6) 2024, BEFORE CONNECTING THE PATIENT, A HAMILTON C3 VENTILATOR (SN (B)(6), SHOWED LOSS OF EXTERNAL POWER ALARM. VENTILATION HAS ALARMED WITH BATTERY LOW (MEDIUM AND HIGH PRIORITY ALARM). THE TECHNICAL FAULT 444001 APPEARS IN THE EVENT LOG (HIGH PRIORITY ALARM) = VENTILATION STOPS (AMBIENT MODE). UNIT ALARMS WITH 244001 EXTERNALPOWERLOSS AND CONTINUES ON BATTERY POWER = VENTILATION CONTINUES CHECKED THE POWER SUPPLY AND FOUND THERE IS NO OUTPUT VOLTAGE FROM IT. AS AN IMMEDIATE CORRECTIVE ACTION, REPLACEMENT WITH NEW POWER SUPPLY. NOW, MACHINE IS WORKING WELL. ALL TESTS AND CALIBRATIONS WERE DONE. INVESTIGATION PERFORMED REVEALED THE FOLLOWING: LOG FILES SHOWED THE FOLLOWING TECHINICAL FAULTS: TF 444001 (BATTERIES COMPLETELY DISCHARGED) TF 485001 AMBIENT MODE IDENTIFIED ROOT CAUSE ASSOCIATED TO THIS ISSUE COULD BE RELATED TO THE FOLLOWING: BAD CONNECTION. DEFECTIVE POWER SUPPLY. DEFECTIVE MAINBOARD. A USER ERROR AS THE WARNINGS DISPLAYED HAVE NOT BEEN REGARDED. BATTERIES COMPLETELY DISCHARGED DUE TO: MAINS POWER NOT CONNECTED OR NOT AVAILABLE, OR DEFECTIVE POWER SUPPLY WRONG BATTERY VALUES DUE TO: UNCALIBRATED BATTERY END OF LIFE REACHED ACCORDINGLY, THE FOLLOWING CORRECTION ARE CONSIDERED: 1. CHECK FOR A DEFECTIVE POWER SUPPLY IF 24 V AT MAINBOARD (MEASURED BETWEEN PIN GND_POWER AND PIN +24V_PS) IS NOT AVAILABLE EXCHANGE POWER SUPPLY. 2. CHECK FOR A DEFECTIVE MAINBOARD ONCE STEP 1 PASSED CONTINUE AS FOLLOWING. IF 26.8 V AT MAINBOARD (MEASURED BETWEEN PIN GND_POWER AND PIN +24V_BLOWER) IS NOT AVAILABLE EXCHANGE MAINBOARD. NOTE: IF YOU EXCHANGE THE MAINBOARD, CHECK FOR EQUAL REVISION ON MAINBOARD LABEL AND ENTERED REVISION AT THE UNIT. EXCHANGE THE PART ACCORDING THE RESULTS ABOVE: DEFECTIVE POWER SUPPLY DEFECTIVE MAINBOARD ACCORDING TO THE AVAILABLE INFORMATION, THERE IS NO INDICATION THAT THE COMPLAINT LEAD TO DEATH, INJURY OR SERIOUS DETERIORATION OF THE HEALTH OF THE PATIENT, USER OR THIRD-PARTY.

    Description of Event or Problem · 0

    THE FOLLOWING HAS BEEN REPORTED TO HAMILTON MEDICAL AG ON 19 JUNE 2024. IT WAS REPORTED THAT ON (B)(6) 2024, BEFORE CONNECTING THE PATIENT, A HAMILTON C3 VENTILATOR (SN (B)(6)), SHOWED LOSS OF EXTERNAL POWER ALARM. VENTILATION HAS ALARMED WITH BATTERY LOW (MEDIUM AND HIGH PRIORITY ALARM). THE TECHNICAL FAULT 444001 APPEARS IN THE EVENT LOG (HIGH PRIORITY ALARM) VENTILATION STOPS (AMBIENT MODE). UNIT ALARMS WITH 244001 EXTERNAL POWER LOSS AND CONTINUES ON BATTERY POWER VENTILATION CONTINUES CHECKED THE POWER SUPPLY AND FOUND THERE IS NO OUTPUT VOLTAGE FROM IT. AS AN IMMEDIATE CORRECTIVE ACTION, REPLACEMENT WITH NEW POWER SUPPLY. NOW, MACHINE IS WORKING WELL. ALL TESTS AND CALIBRATIONS WERE DONE. INVESTIGATION PERFORMED REVEALED THE FOLLOWING: LOG FILES SHOWED THE FOLLOWING TECHINICAL FAULTS: TF 444001 (BATTERIES COMPLETELY DISCHARGED), TF 485001 AMBIENT MODE. IDENTIFIED ROOT CAUSE ASSOCIATED TO THIS ISSUE COULD BE RELATED TO THE FOLLOWING: BAD CONNECTION, DEFECTIVE POWER SUPPLY, DEFECTIVE MAINBOARD. A USER ERROR AS THE WARNINGS DISPLAYED HAVE NOT BEEN REGARDED. BATTERIES COMPLETELY DISCHARGED DUE TO: MAINS POWER NOT CONNECTED OR NOT AVAILABLE, OR DEFECTIVE POWER SUPPLY. WRONG BATTERY VALUES DUE TO: UNCALIBRATED BATTERY, END OF LIFE REACHED. ACCORDINGLY, THE FOLLOWING CORRECTION ARE CONSIDERED: 1. CHECK FOR A DEFECTIVE POWER SUPPLY IF 24 V AT MAINBOARD (MEASURED BETWEEN PIN GND_POWER AND PIN +24V_PS) IS NOT AVAILABLE EXCHANGE POWER SUPPLY. 2. CHECK FOR A DEFECTIVE MAINBOARD ONCE STEP 1 PASSED CONTINUE AS FOLLOWING. IF 26.8 V AT MAINBOARD (MEASURED BETWEEN PIN GND_POWER AND PIN +24V_BLOWER) IS NOT AVAILABLE EXCHANGE MAINBOARD. NOTE: IF YOU EXCHANGE THE MAIN BOARD, CHECK FOR EQUAL REVISION ON MAIN BOARD LABEL AND ENTERED REVISION AT THE UNIT. EXCHANGE THE PART ACCORDING TO THE RESULTS ABOVE: DEFECTIVE POWER SUPPLY, DEFECTIVE MAINBOARD. ACCORDING TO THE AVAILABLE INFORMATION, THERE IS NO INDICATION THAT THE COMPLAINT LED TO DEATH, INJURY OR SERIOUS DETERIORATION OF THE HEALTH OF THE PATIENT, USER OR THIRD-PARTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480499 HAMILTON-C3 HAMILTON-C3 CBK HAMILTON MEDICAL AG 160005 07630002801881

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention