BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-T1

    MDR report key: 20211215 · Received September 13, 2024

    Report

    Report Number
    3001421318-2024-02209
    Event Type
    Malfunction
    Date Received
    September 13, 2024
    Date of Event
    November 14, 2023
    Report Date
    November 17, 2025
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    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: "TECHNICAL FAULT 431009 (QO2 SENSOR DEFECT) AND 231013." NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1263099 HAMILTON-T1 HAMILTON-T1 CBK HAMILTON MEDICAL AG MSP161179

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown