BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-C1

    MDR report key: 20554912 · Received October 29, 2024

    Report

    Report Number
    3001421318-2024-02600
    Event Type
    Malfunction
    Date Received
    October 29, 2024
    Date of Event
    October 14, 2024
    Report Date
    October 29, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002800747
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG CASE NUMBER IS: CER (B)(4). FOLLOW-UP NR. 1 INFORMATION: UDI AND MANUFACTURING DATE CORRECTED/ADDED IN FIELDS D4 AND H4.

    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: ON (B)(6) 2024, WHEN USING THIS EQUIPMENT IN THE ICU OF THE BRAIN CENTER OF (B)(6) HOSPITAL IN (B)(6) CITY, THE EXHALATION VALVE OF THE EQUIPMENT LEAKED AND COULD NOT BE USED NORMALLY. THE EQUIPMENT DEPARTMENT WAS IMMEDIATELY REPORTED FOR REPAIR. NO HEALTH CONSEQUENCES OR IMPACT.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: ON (B)(6) 2024, WHEN USING THIS EQUIPMENT IN THE ICU OF THE BRAIN CENTER OF CHIPING DISTRICT PEOPLE'S HOSPITAL IN LIAOCHENG CITY, THE EXHALATION VALVE OF THE EQUIPMENT LEAKED AND COULD NOT BE USED NORMALLY. THE EQUIPMENT DEPARTMENT WAS IMMEDIATELY REPORTED FOR REPAIR. NO HEALTH CONSEQUENCES OR IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303313 HAMILTON-C1 HAMILTON-C1 CBK HAMILTON MEDICAL AG 161001 07630002800747

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown