BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 19728291 · Received July 12, 2024

    Report

    Report Number
    3001421318-2024-01680
    Event Type
    Malfunction
    Date Received
    July 12, 2024
    Date of Event
    June 11, 2024
    Report Date
    November 26, 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 Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG CASE NUMBER IS: CER (B)(4).

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4). FOLLOW-UP 1 - CORRECTED INFORMATION: UDI RELATED DATA QUALITY UPDATES ONLY. WITHIN THE UDI-PI PROJECT, HAMILTON MEDICAL REALIZED THAT THE REPORTED DEVICE (BRAND NAME: HAMILTON-C1; VERSION / MODEL / 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.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: UNDER INSPECTION, WHEN HOSPITAL STAFF ATTEMPTED TO CHECK THE OPERATION OF THIS C1 AFTER PATIENT USE, THE SCREEN REMAINED DARK AND THE ALARM CONTINUED TO SOUND. LOCAL STAFF INTEND TO REPAIR THIS C1. NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: UNDER INSPECTION, WHEN HOSPITAL STAFF ATTEMPTED TO CHECK THE OPERATION OF THIS C1 AFTER PATIENT USE, THE SCREEN REMAINED DARK AND THE ALARM CONTINUED TO SOUND. LOCAL STAFF INTEND TO REPAIR THIS C1. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2380202 HAMILTON MEDICAL AG HAMILTON-C1 CBK HAMILTON MEDICAL AG HAMILTON-C1 07630002800747

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown