BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-C1

    MDR report key: 17938181 · Received October 16, 2023

    Report

    Report Number
    3001421318-2023-03534
    Event Type
    Malfunction
    Date Received
    October 16, 2023
    Date of Event
    September 25, 2023
    Report Date
    September 6, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002800747
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG CASE NUMBER IS: (B)(4). WITHIN THE UDI-PI PROJECT, HAMILTON MEDICAL DID REALIZE THAT THE REPORTED DEVICE BRAND NAME: HAMILTON-C1, MODEL NUMBER: 161003, CATALOG NUMBER: 161003 IN THE PRESENT MDR IS NOT FULFILLING THE CRITERIA OF SIMILARITY FOR A DEVICE MARKETED IN THE U.S., THEREFORE THIS EVENT IS NO LONGER CONSIDERED REPORTABLE TO FDA AND NO UDI-PI IS GOING TO BE PROVIDED.

    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: LOCAL STAFF WAS WORKING ON A REPLACEMENT REPAIR FOR C1. HE OPENED A NEW OXYGEN MIXER BLOCK AND TRIED TO INSTALL IT IN C1. HOWEVER, THE NEW OXYGEN MIXER BLOCK DID NOT WORK. EVEN AFTER CHANGING THE OXYGEN LEVEL SETTING, THE OXYGEN LEVEL WOULD ONLY GO UP TO 28-29%. HE REPLACED THE HIGH-PRESSURE OXYGEN HOSE AND CHECKED THE HIGH-PRESSURE OXYGEN PRESSURE, BUT THE PROBLEM PERSISTED. NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: LOCAL STAFF WAS WORKING ON A REPLACEMENT REPAIR FOR C1. HE OPENED A NEW OXYGEN MIXER BLOCK AND TRIED TO INSTALL IT IN C1. HOWEVER, THE NEW OXYGEN MIXER BLOCK DID NOT WORK. EVEN AFTER CHANGING THE OXYGEN LEVEL SETTING, THE OXYGEN LEVEL WOULD ONLY GO UP TO 28-29%. HE REPLACED THE HIGH-PRESSURE OXYGEN HOSE AND CHECKED THE HIGH-PRESSURE OXYGEN PRESSURE, BUT THE PROBLEM PERSISTED. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1286188 HAMILTON-C1 HAMILTON-C1 CBK HAMILTON MEDICAL AG 161003 07630002800747

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown