BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-C6

    MDR report key: 21318936 · Received February 6, 2025

    Report

    Report Number
    3001421318-2025-00227
    Event Type
    Malfunction
    Date Received
    February 6, 2025
    Date of Event
    December 22, 2024
    Report Date
    July 21, 2025
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002808590
    PMA / PMN Number
    K201658
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG`S CONCLUSION: INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: HAMILTON MEDICAL AG`S COMES TO THE FOLLOWING CONCLUSION: THE USER REPORTED A WHISTLING NOISE FROM THE BACK OF THE VENTILATOR AT HIGH TURBINE SPEED. THE EVENT OCCURRED IN A NON-CLINICAL SETTING; NO PATIENT WAS INVOLVED. NO HARM OR TREATMENT DELAY WAS REPORTED. THE DEVICE STILL WORKED AS INTENDED EVEN WITH A ¿NOISY FAN¿. NO LOGFILES WERE MADE AVAILABLE. BASED ON THE TECHNICIAN¿S ASSESSMENT, THE ROOT CAUSE WAS A DEFECTIVE BOTTOM FAN (PN 160856). THE FAN (C6 BOTTOM FAN 12V, PN 160856) WAS REPLACED. THE DEVICE PASSED ALL SERVICE TESTS AND WAS RETURNED TO USE. NO FURTHER ACTION REQUIRED.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDIAL AG: COMPLAINT DESCRIPTION (QUOTATION OF THE CUSTOMER/REPORTER): "THE USER COMPLAINED ABOUT THE VOLUME AT HIGH TURBINE SPEED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    909565 HAMILTON-C6 HAMILTON-C6 CBK HAMILTON MEDICAL AG 160021 07630002808590

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown