BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-C3

    MDR report key: 19601518 · Received June 24, 2024

    Report

    Report Number
    3001421318-2024-01424
    Event Type
    Malfunction
    Date Received
    June 24, 2024
    Date of Event
    May 8, 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: (B)(4). 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 05 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 FREQUENTLY. BATTERY IS NOT CHARGING. POWER SUPPLY OUTPUT VOLTAGE IS LESS THAN 20 V. REPLACED NEW POWER SUPPLY. NOW MACHINE IS WORKING FINE. ALL TESTS AND CALIBRATIONS WERE DO. INVESTIGATION PERFORMED REVEALED THE FOLLOWING: IN STAND BY MODE, UNIT ALARMS WITH EXTERNAL POWERLOSS AND CONTINUES ON BATTERY POWER. UNIT ALARMS WITH 244001 EXTERNALPOWERLOSS AND CONTINUES ON BATTERY POWER. VENTILATION CONTINUES. IDENTIFIED ROOT CAUSE ASSOCIATED TO THIS ISSUE COULD BE RELATED TO: BAD CONNECTION. DEFECTIVE POWER SUPPLY. DEFECTIVE MAINBOARD. 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 05 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 FREQUENTLY. BATTERY IS NOT CHARGING. POWER SUPPLY OUTPUT VOLTAGE IS LESS THAN 20 V. REPLACED NEW POWER SUPPLY. NOW MACHINE IS WORKING FINE. ALL TESTS AND CALIBRATIONS WERE DO INVESTIGATION PERFORMED REVEALED THE FOLLOWING: - IN STAND BY MODE, UNIT ALARMS WITH EXTERNAL POWERLOSS AND CONTINUES ON BATTERY POWER. - UNIT ALARMS WITH 244001 EXTERNALPOWERLOSS AND CONTINUES ON BATTERY POWER. VENTILATION CONTINUES. IDENTIFIED ROOT CAUSE ASSOCIATED TO THIS ISSUE COULD BE RELATED TO: - BAD CONNECTION. - DEFECTIVE POWER SUPPLY. - DEFECTIVE MAINBOARD. 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 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
    1712056 HAMILTON-C3 HAMILTON-C3 CBK HAMILTON MEDICAL AG 160005 07630002801881

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention