BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-C1

    MDR report key: 20350632 · Received October 2, 2024

    Report

    Report Number
    3001421318-2024-02360
    Event Type
    Malfunction
    Date Received
    October 2, 2024
    Date of Event
    August 8, 2024
    Report Date
    October 2, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002800747
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    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: AT THE TIME OF TESTING, INSPECTED VENTILATOR SHOWING ERROR 232056 (PLAUSIBILITY BETWEEN PAMBIENT AND PFILTER FAILED) AND SELF TEST FAILED NO PATIENT INVOLVEMENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2369835 HAMILTON-C1 HAMILTON-C1 CBK HAMILTON MEDICAL AG 161001 07630002800747

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown