BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-G5

    MDR report key: 22216911 · Received June 17, 2025

    Report

    Report Number
    3001421318-2025-00653
    Event Type
    Malfunction
    Date Received
    June 17, 2025
    Date of Event
    May 30, 2025
    Report Date
    September 23, 2025
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002802208
    PMA / PMN Number
    K193228
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG REFERENCE NUMBER: (B)(4) INVESTIGATION ONGLONG.

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG REFERENCE NUMBER: (B)(4). FOLLOW-UP 1: DEVICE EVALUATION. ACCORDING TO THE COMPLAINT DESCRIPTION, THE DEVICE ALARMED WITH TF5507. NO HARM TO THE PATIENT WAS REPORTED THE LOGFILE SHOWS THE REPORTED TF 5507. 2025-05-30 02:09:13 AUDIO PAUSED OFF SPECIAL 517. 2025-05-30 02:09:13 TF : 5507 TECH FAULT 5507. 2025-05-30 02:08:43 AUDIO PAUSED ON SPECIAL 516. 2025-05-30 02:08:41 OXYGEN 80 % SETTING 302. 2025-05-30 02:08:39 AUDIO PAUSED OFF SPECIAL 517. 2025-05-30 02:08:39 TF: 5507 TECH FAULT 5507. ACCORDING TO THE INFORMATION RECEIVED, THE ROOT CAUSE WAS IDENTIFIED AS A DEFECTIVE SENSOR BOARD. A SENSOR BOARD WAS SHIPPED TO THE CUSTOMER. ACCORDING TO THE PARTNER, THIS RESOLVED THE REPORTED PROBLEM.

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: THE DEVICE ALARMED WITH TF:5507. ALARM WAS TRIGGERED WHEN ADJUSTING O2 AND IT DID NOT REACH SETTING. THE VENTILATOR WAS EXCHANGED. NO HARM TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1007799 HAMILTON-G5 HAMILTON-G5 CBK HAMILTON MEDICAL AG 159002 07630002802208

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown