BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 17497032 · Received August 10, 2023

    Report

    Report Number
    3001421318-2023-02859
    Event Type
    Malfunction
    Date Received
    August 10, 2023
    Date of Event
    August 1, 2023
    Report Date
    August 1, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002808590
    PMA / PMN Number
    K201658
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG CASE NUMBER IS: (B)(4). ROOT CAUSE: DEFECTIVE PRESSURE SENSOR ASSEMBLY. LEAK IN PRESSSURE SENSOR ASSEMBLY. CORRECTION: REPLACEMENT OF THE PRESSURE SENSOR ASSEMBLY.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: PRESSURE SENSOR ASSEMBLY TEST FAILED FOR 100MBAR PAW DISPLAY 82,9MBAR AND QAW:2,6L/MIN NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1280190 HAMILTON MEDICAL AG HAMILTON-C6 CBK HAMILTON MEDICAL AG HAMILTON-C6 07630002808590

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown