BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-C1

    MDR report key: 18117751 · Received November 13, 2023

    Report

    Report Number
    3001421318-2023-03823
    Event Type
    Malfunction
    Date Received
    November 13, 2023
    Date of Event
    October 5, 2023
    Report Date
    August 15, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002800747
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

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

    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: LEAKING OR DEFECTIVE DISTAL AUTOZERO VALVE (TECHNICAL EVENT: (B)(4)) AUTOZERO AIRWAY TEST FAILED. AUTOZERO ERROR QAW/PAW. NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: LEAKING OR DEFECTIVE DISTAL AUTOZERO VALVE (TECHNICAL EVENT:233004). AUTOZERO AIRWAY TEST FAILED. AUTOZERO ERROR QAW/PAW. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2108929 HAMILTON-C1 HAMILTON-C1 CBK HAMILTON MEDICAL AG 161001 07630002800747

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown