BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAMILTON-G5

    MDR report key: 18404837 · Received December 27, 2023

    Report

    Report Number
    3016723884-2023-00030
    Event Type
    Injury
    Date Received
    December 27, 2023
    Date of Event
    December 9, 2023
    Report Date
    December 27, 2023
    Manufacturer
    HAMILTON MEDCIAL AG
    Product Code
    CBK
    UDI-DI
    07630002800013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    BIOMED SAID THE UNIT WAS ON A PATIENT, THE SCREEN LOST THE VITALS AND STOPPED RESPONDING TO TOUCH SCREEN SELECTION. THEY RECENTLY UPDATED THE UNIT TO 2.90 SOFTWARE, AND THEY WANTED ONSITE SERVICE JUST IN CASE IT WAS RELATED TO THE UPGRADE. 2023-12-09 18:10:21 TF : 2801 456 TECH FAULT 2801. 2023-12-09 18:10:21 TF : 2802 11 TECH FAULT 2802. 2023-12-09 18:10:21 TF : 2801 544 TECH FAULT 2801.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2264281 HAMILTON-G5 HAMILTON-G5 CBK HAMILTON MEDCIAL AG HAMILTON-G5 07630002800013

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| R