BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 17214782 · Received June 28, 2023

    Report

    Report Number
    3001421318-2023-02469
    Event Type
    Malfunction
    Date Received
    June 28, 2023
    Date of Event
    May 9, 2023
    Report Date
    June 28, 2023
    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 CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG AHS NOT RECEIVED THE DEVICE FOR INVESTGATION. HOWEVER, WE WERE INFORMED THAT AFTER THE MAINTENANCE PERSONNEL REPLACED THE SEALING RING ON THE OXYGEN CONNECTION PIPE AND CONNECTED THE EQUIPMENT AGAIN, THE EQUIPMENT NO LONGER LEAKED AIR. HAMILTON MEDICAL AG CASE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: THE REPORT FROM HOSPITAL SAY: ON (B)(6) 2023, MEDICAL STAFF FOUND AIR LEAKAGE DURING THEIR DAILY INSPECTION OF THE DEVICE AND IMMEDIATELY REPORTED IT TO THE HOSPITAL'S INSTRUMENT DEPARTMENT. THE MAINTENANCE PERSONNEL FROM THE EQUIPMENT DEPARTMENT ARRIVED FOR INSPECTION AND FOUND THAT THE OXYGEN CONNECTION PIPE WAS LOOSE AFTER BEING CONNECTED TO THE MACHINE, RESULTING IN AIR LEAKAGE. THE CONNECTION HEAD AND PIPELINE WERE ORIGINALLY EQUIPPED BY THE FACTORY NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148709 HAMILTON MEDICAL AG HAMILTON-C1 CBK HAMILTON MEDICAL AG HAMILTON-C1 07630002800747

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown