BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-C1

    MDR report key: 19379183 · Received May 23, 2024

    Report

    Report Number
    3001421318-2024-01277
    Event Type
    Malfunction
    Date Received
    May 23, 2024
    Date of Event
    April 26, 2024
    Report Date
    October 24, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002800747
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG CASE NUMBER IS: (B)(4). FOLLOW-UP 1 - CORRECTED INFORMATION: UDI RELATED DATA QUALITY UPDATES ONLY. FIELD D4 WAS UPDATED WITH FULL UDI INFORMATION.

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG CASE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: ON APRIL 26, 2024, THE DEPARTMENT PROVIDED DAILY MAINTENANCE FOR THE EQUIPMENT. DURING STARTUP TESTING, THE VENTILATOR TRIGGERED AN ALARM, INDICATING AN OXYGEN CONCENTRATION ALARM AND UNABLE TO MONITOR OXYGEN CONCENTRATION IN REAL TIME. CONSIDERING THE RISK INVOLVED, THE DEVICE WAS IMMEDIATELY LABELED AS FAULTY AND THE HOSPITAL EQUIPMENT DEPARTMENT WAS CONTACTED FOR MAINTENANCE. AFTER INSPECTION, IT IS SUSPECTED THAT THE EXPIRATION OF THE OXYGEN BATTERY OF THE VENTILATOR IS THE CAUSE. AFTER CONTACTING THE SUPPLIER TO ORDER A NEW OXYGEN BATTERY FOR REPLACEMENT, THE EQUIPMENT RETURNED TO NORMAL. NO ADVERSE EFFECTS WERE CAUSED. NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: ON APRIL 26, 2024, THE DEPARTMENT PROVIDED DAILY MAINTENANCE FOR THE EQUIPMENT. DURING STARTUP TESTING, THE VENTILATOR TRIGGERED AN ALARM, INDICATING AN OXYGEN CONCENTRATION ALARM AND UNABLE TO MONITOR OXYGEN CONCENTRATION IN REAL TIME. CONSIDERING THE RISK INVOLVED, THE DEVICE WAS IMMEDIATELY LABELED AS FAULTY AND THE HOSPITAL EQUIPMENT DEPARTMENT WAS CONTACTED FOR MAINTENANCE. AFTER INSPECTION, IT IS SUSPECTED THAT THE EXPIRATION OF THE OXYGEN BATTERY OF THE VENTILATOR IS THE CAUSE. AFTER CONTACTING THE SUPPLIER TO ORDER A NEW OXYGEN BATTERY FOR REPLACEMENT, THE EQUIPMENT RETURNED TO NORMAL. NO ADVERSE EFFECTS WERE CAUSED. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1768726 HAMILTON-C1 HAMILTON-C1 CBK HAMILTON MEDICAL AG 161001 07630002800747

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown