BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-C1

    MDR report key: 19133757 · Received April 18, 2024

    Report

    Report Number
    3001421318-2024-00959
    Event Type
    Malfunction
    Date Received
    April 18, 2024
    Date of Event
    April 4, 2024
    Report Date
    November 12, 2025
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002800747
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG CASE NUMBER IS: CER (B)(4). FOLLOW-UP 1 - CORRECTED INFORMATION: **UDI RELATED DATA QUALITY UPDATES ONLY** FIELD D4 WAS UPDATED WITH FULL UDI INFORMATION.

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG CASE NUMBER IS: CER (B)(4).

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: BIOMED STATED C1 DISPLAYED TF 233004 (AUTOZERO ERROR QAW/PAW) WHILE VENTING A PATIENT. PATIENT WAS MOVE TO AN ALTERNATE VENT. NO HARM TO PATIENT. WHILE GOING THROUGH SERVICE SOFTWARE, THERE WERE MULTIPLE TESTS THAT FAILED. NO HEALTH CONSEQUENCES OR IMPACT.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: BIOMED STATED C1 DISPLAYED TF 233004 (AUTOZERO ERROR QAW/PAW) WHILE VENTING A PATIENT. PATIENT WAS MOVE TO AN ALTERNATE VENT. NO HARM TO PATIENT. WHILE GOING THROUGH SERVICE SOFTWARE, THERE WERE MULTIPLE TESTS THAT FAILED. NO HEALTH CONSEQUENCES OR IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2288954 HAMILTON-C1 HAMILTON-C1 CBK HAMILTON MEDICAL AG 161001 07630002800747

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown