BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-C1

    MDR report key: 18736916 · Received February 20, 2024

    Report

    Report Number
    3001421318-2024-00401
    Event Type
    Malfunction
    Date Received
    February 20, 2024
    Date of Event
    February 6, 2024
    Report Date
    October 28, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002813426
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    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. UPDATED FIELDS: B4, D1, D4, G6, H2, H4, H11.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: TF 233004 APPEARED IN THE SERVICE MENU NO FLOW SENSOR CALIBRATION POSSIBLE PROX. FLOW SENSOR QAW DISPLAY IMPLAUSIBLE NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: TF 233004 APPEARED IN THE SERVICE MENU. NO FLOW SENSOR CALIBRATION POSSIBLE. PROX. FLOW SENSOR QAW DISPLAY IMPLAUSIBLE. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1067300 HAMILTON-C1 HAMILTON-C1 CBK HAMILTON MEDICAL AG 1610010 07630002813426

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown