BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-C6

    MDR report key: 19905080 · Received August 5, 2024

    Report

    Report Number
    3001421318-2024-01838
    Event Type
    Malfunction
    Date Received
    August 5, 2024
    Date of Event
    July 27, 2024
    Report Date
    August 5, 2024
    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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMES TO THE CONCLUSION: ROOTCAUSE: DEFECTIVE INSPIRATORY VALVE. CORRECTION: REPLACED DEFECTIVE COMPONENT.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: TECHNICAL EBENT (TE) 231005.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2301888 HAMILTON-C6 HAMILTON-C6 CBK HAMILTON MEDICAL AG 160021 07630002808590

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown