BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-C3

    MDR report key: 18824656 · Received March 4, 2024

    Report

    Report Number
    3001421318-2024-00492
    Event Type
    Malfunction
    Date Received
    March 4, 2024
    Date of Event
    February 21, 2024
    Report Date
    October 31, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002801881
    PMA / PMN Number
    K201306
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMES TO THE CONCLUSION: ROOT CAUSE: THE "INSPIRATORY VALVE" HAS BEEN IDENTIFIED TO BE THE FAULTY COMPONENT. CORRECTION: REPLACED DEFECTIVE COMPONENT.

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMES TO THE CONCLUSION: ROOT CAUSE: THE "INSPIRATORY VALVE" HAS BEEN IDENTIFIED TO BE THE FAULTY COMPONENT. CORRECTION: REPLACED DEFECTIVE COMPONENT. HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4). FOLLOW-UP 1 - CORRECTED INFORMATION: **UDI RELATED DATA QUALITY UPDATES ONLY** FIELD D4 WAS UPDATED WITH FULL UDI INFORMATION, UPDATED FIELDS: B4, D1, D2A, D4, D8, G1, G2, G6, H2, H4, H5.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY:FLOW SENSOR CALIBRATION FAILED. DEVICE IS SHOWING TE 231005 INTERMITTENTLY.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY:FLOW SENSOR CALIBRATION FAILED. DEVICE IS SHOWING TE 231005 INTERMITTENTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709420 HAMILTON-C3 HAMILTON-C3 CBK HAMILTON MEDICAL AG 160005 07630002801881

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown