BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 17285829 · Received July 10, 2023

    Report

    Report Number
    3001421318-2023-02578
    Event Type
    Malfunction
    Date Received
    July 10, 2023
    Date of Event
    June 14, 2023
    Report Date
    July 10, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002800747
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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: TE 232002, TE233001, TE233004. SELF TEST FAILED. AUTOZERO , PRESSURE, FLOW SENSOR AND EXP VALVE TEST FAILED. NO PATIENT INVOLVEMENT. HAMILTON MEDICAL AG ADDITION: TE 232002 (PVENT_MONITOR DEFECT) AND TE 233001 (PVENT_MONITOR AUTOZERO FAILED) LEADS TO SELFTEST FAILED. DEVICE CANNOT BE USED FOR VENTILATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1542486 HAMILTON MEDICAL AG HAMILTON-C1 CBK HAMILTON MEDICAL AG HAMILTON-C1 07630002800747

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown