BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-C1

    MDR report key: 21109383 · Received January 9, 2025

    Report

    Report Number
    3001421318-2025-00075
    Event Type
    Malfunction
    Date Received
    January 9, 2025
    Date of Event
    December 23, 2024
    Report Date
    November 16, 2025
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG RECEIVED A COMPLAINT ABOUT A HAMILTON-C1 DEVICE. ACCORDING TO THE LOGFILES TE 232003 (PAW SENSOR DEFECT) ALARMED. THIS RECORD CONTAINS NO INFORMATION ABOUT THE CIRCUMSTANCES. IT IS UNKNOWN WHETHER THE PROBLEM WAS IDENTIFIED DURING VENTILATION OR NOT. ATTEMPTS HAVE BEEN MADE TO OBTAIN INFORMATION, AND NOTHING HAS BEEN PROVIDED. THE LOGFILES RECEIVED DO NOT COVER THE REPORTED DATE OF EVENT (B)(6) 2024. ACCORDING TO THE EVENT LOG TE 232003 (PAW SENSOR DEFECT) WAS ALARMED ON (B)(6) 2024. BASED ON THE LACK OF INFORMATION, NO CONCLUSION COULD BE RAISED. REASONABLE EFFORT TO GET INFORMATION WAS CONDUCTED.

    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 EVENT:232003 PAW SENSOR DEFECT NO HEALTH CONSEQUENCES OR IMPACT. NO INFORMATION ABOUT PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1376745 HAMILTON-C1 HAMILTON-C1 CBK HAMILTON MEDICAL AG 161001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown