BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-C1

    MDR report key: 18362085 · Received December 20, 2023

    Report

    Report Number
    3001421318-2023-04276
    Event Type
    Malfunction
    Date Received
    December 20, 2023
    Date of Event
    November 12, 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
    505

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG CASE NUMBER IS: CER 144790. 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: DURING AN INSPECTION AT THE END OF OCTOBER, THE LOCAL STAFF REPLACED THE REGULAR REPLACEMENT PARTS, INCLUDING THE O2 CELL. HOWEVER, IN NOVEMBER, HOSPITAL STAFF COMPLAINED OF FREQUENT LOW OXYGEN ALARMS. NO PATIENT HARM OR CONSEQUENCES.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: DURING AN INSPECTION AT THE END OF OCTOBER, THE LOCAL STAFF REPLACED THE REGULAR REPLACEMENT PARTS, INCLUDING THE O2 CELL. HOWEVER, IN NOVEMBER, HOSPITAL STAFF COMPLAINED OF FREQUENT LOW OXYGEN ALARMS. NO PATIENT HARM OR CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2162893 HAMILTON-C1 HAMILTON-C1 CBK HAMILTON MEDICAL AG 161003 07630002800747

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown