BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-C1

    MDR report key: 16674440 · Received April 4, 2023

    Report

    Report Number
    3001421318-2023-01213
    Event Type
    Malfunction
    Date Received
    April 4, 2023
    Date of Event
    March 15, 2023
    Report Date
    January 27, 2025
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002800747
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    O2 MIXER DEFECTIVE. MIXER WAS REPLACED AND THE DEVICE WORKED AS INTENDED. HAMILTON MEDICAL AG CASE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    O2 MIXER DEFECTIVE. MIXER WAS REPLACED AND THE DEVICE WORKED AS INTENDED. HAMILTON MEDICAL AG CASE NUMBER IS: CER (B)(4) HAMILTON MEDICAL AG COMPLAINT NUMBER: CER (B)(4) FOLLOW-UP 1 - DEVICE EVALUATION: ROOT CAUSE: THE EVENT LOG CONFIRMS OCCURRENCE OF THE TECHNICAL EVENT 231008 WHEN THE DEVICE WAS STARTED-UP IN SERVICE MODE. NO HARDWARE ANALYSIS HAS BEEN PERFORMED AS THE PART WAS NOT RETURNED FOR INVESTIGATION. A REASON FOR TRIGGERING THIS ALARM CONDITION COULD BE BECAUSE OF A: -DEFECTIVE O2 MIXER (O2 VALVE NOT PROPERLY CLOSING. MECHANICALLY OR ELECTRONICALLY) -LEAK ON THE LPO INLET OR BETWEEN O2 MIXER AND QO2 SENSOR. IN THIS CASE BLOWER SUCKS THE AIR THROUGH THE LPO ADAPTER THROUGH QO2 SENSOR, WHICH CREATES A FALSE POSITIVE ALARM. -LPO ADAPTER (QUICK CONNECT COUPLING) IS STILL INSERTED, WHILE THE DEVICE IS SET TO HPO. IN THIS CASE BLOWER SUCKS THE AIR OVER THE LPO ADAPTER THROUGH QO2 SENSOR, WHICH CREATES A FALSE POSITIVE ALARM -> USER ERROR -DRIVER BOARD AS CAUSE. THE O2 VALVE DRIVER STAGE CONTROLS THE O2 PROPORTIONAL VALVE AND IS LOCATED ON THE DRIVER BOARD. AS STATED IN THIS COMPLAINT CASE, THE O2 MIXER ASSEMBLY WAS REPLACED AND THE DEVICE IS FUNCTIONING AGAIN. IN AGREEMENT WITH THE FDA, UDI NUMBERS (FIELD D4 IN THIS FORM) ARE ONLY PROVIDED FOR INCIDENTS THAT HAVE BEEN INITIALLY REPORTED BY HAMILTON MEDICAL AG SINCE OCTOBER 1ST, 2023. UPDATED FIELDS: B4, D1, D4, G1, G3, G6, H2, H4, H6, H7, H11.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: TF231008 GIVES THIS ERROR AT INDEFINITE TIMES BUT TSW TESTS PASS SUCCESSFULLY. IN NORMAL VENTILATION, THERE IS A 6 UNIT DIFFERENCE BETWEEN THE ADJUSTED AND MEASURED OXYGEN, AND IT DROPS TO 2 UNITS WITHOUT AN ALARM. NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: TF231008 GIVES THIS ERROR AT INDEFINITE TIMES BUT TSW TESTS PASS SUCCESSFULLY. IN NORMAL VENTILATION, THERE IS A 6 UNIT DIFFERENCE BETWEEN THE ADJUSTED AND MEASURED OXYGEN, AND IT DROPS TO 2 UNITS WITHOUT AN ALARM. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386796 HAMILTON-C1 HAMILTON-C1 CBK HAMILTON MEDICAL AG 161001 07630002800747

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown