BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-C1

    MDR report key: 18710718 · Received February 15, 2024

    Report

    Report Number
    3001421318-2024-00369
    Event Type
    Malfunction
    Date Received
    February 15, 2024
    Date of Event
    January 15, 2024
    Report Date
    October 21, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002800747
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG CASE NUMBER IS: CER (B)(4). THE TECHNICIAN REPLACED THE BLOWER MODULE WITH NEW ONE. THE DEVICE IS FUNCTIONING AS INTENDED. THEREFORE, THE BLOWER WAS FOUND TO BE THE ROOT CAUSE.

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG CASE NUMBER IS: CER (B)(4). THE TECHNICIAN REPLACED THE BLOWER MODULE WITH NEW ONE. THE DEVICE IS FUNCTIONING AS INTENDED. THEREFORE, THE BLOWER WAS FOUND TO BE THE ROOT CAUSE. FOLLOW-UP 1 - CORRECTED INFORMATION: **UDI RELATED DATA QUALITY UPDATES ONLY** FIELD D4 WAS UPDATED WITH FULL UDI INFORMATION.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: TECHNICAL EVENTS:232005 (ALARM BLOWER TEMP HIGH). NO PATIENT HARM OR CONSEQUENCES.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: TECHNICAL EVENTS:232005 (ALARM BLOWER TEMP HIGH) NO PATIENT HARM OR CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482593 HAMILTON-C1 HAMILTON-C1 CBK HAMILTON MEDICAL AG 161001 07630002800747

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown