BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 17179890 · Received June 22, 2023

    Report

    Report Number
    3001421318-2023-02444
    Event Type
    Malfunction
    Date Received
    June 22, 2023
    Date of Event
    May 25, 2023
    Report Date
    June 21, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002808590
    PMA / PMN Number
    K201658
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LG
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMES TO THE CONCLUSION: ROOTCAUSE: DEFECTIVE PARAMAGNETIC SENSOR. CORRECTION: DEFECTIVE PARAMAGNETIC SENSOR REPLACED.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: DETAILED COMPLAINT AND FAILURE DESCRIPTION: SYSTEM TEST: O2 MIXER TEST NOT PASS. PARAMAGNETIC OXYGEN SENSORS: SN. (B)(6). SN. (B)(6). SN. (B)6). INCORRECT FIO2 MONITORING. FOR EXAMPLE: UNIT FIO2 SETTINGS IS 21% MONITORING ABOUT 30%. PARAMAGNETIC O2 SENSOR CALIBRATION PROCESS IS COMPLETED AND STATUS MESSAGE "CALIBRATION OK" IS SHOWN ON THE DISPLAY (TRIED SEVERAL TIMES).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1217654 HAMILTON MEDICAL AG HAMILTON-C6 VENTILATOR CBK HAMILTON MEDICAL AG 160021 07630002808590

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown