BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-C3

    MDR report key: 18674298 · Received February 9, 2024

    Report

    Report Number
    3001421318-2024-00314
    Event Type
    Malfunction
    Date Received
    February 9, 2024
    Date of Event
    January 19, 2024
    Report Date
    October 16, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002801881
    PMA / PMN Number
    K201306
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG CASE NUMBER IS: (B)(4). FOLLOW-UP 2 - CORRECTED INFORMATION: PLEASE NOTE THAT ALL PREVIOUS INFORMATION ABOUT THE AFFECTED DEVICE WAS CORRECTED: THE DEVICE IN QUESTION WAS CONFIRMED TO BE A HAMILTON-C3 (K201306, BRAND NAME: HAMILTON-C3; VERSION / MODEL / CATALOG NUMBER: 160005). ALL CORRESPONDING FIELDS WERE UPDATED, AND ADDITIONALLY, THE SERIAL NUMBER WAS CORRECTED. FIELD D4 WAS UPDATED WITH FULL UDI INFORMATION.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: HAMILTON-C1 VENTILATOR FAILED OXYGEN CALIBRATION UPON STARTUP. NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: HAMILTON-C3 VENTILATOR FAILED OXYGEN CALIBRATION UPON STARTUP. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81251 HAMILTON-C3 HAMILTON-C3 CBK HAMILTON MEDICAL AG 160005 07630002801881

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown