BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-G5

    MDR report key: 17689629 · Received September 6, 2023

    Report

    Report Number
    3001421318-2023-03108
    Event Type
    Malfunction
    Date Received
    September 6, 2023
    Date of Event
    August 8, 2023
    Report Date
    January 17, 2025
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002800013
    PMA / PMN Number
    K193228
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    ALARM LAMP DOES NOT WORK. NEW ALARM LAMP BOARD WAS SENT FOR REPLACEMENT.

    Additional Manufacturer Narrative · 0

    ALARM LAMP DOES NOT WORK. NEW ALARM LAMP BOARD WAS SENT FOR REPLACEMENT. INFORMATION ADDED IN FOLLOW-UP #1 CER 141879. FIELD B4, G6, H2, H3, H6 AND H11 UPDATED. THE ISSUE WAS DISCOVERED DURING SERVICE MAINTENANCE WITH NO PATIENT INVOLVED. CONSEQUENTLY, THE EVENT DID NOT CAUSE OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY. THE MOST PROBABLE ROOT CAUSE OF THE LED FAILURES WAS CHEMICAL CORROSION DUE TO THE GAS PERMEABILITY. THE PARTNER SERVICE TECHNICIAN REPLACED THE ALARM LAMP BOARD PN (B)(6) TO SOLVE THE ISSUE AND PERFORMED THE COMPLETE SERVICE SOFTWARE. THE VENTILATOR WAS THEN RELEASED FOR USE ON THE PATIENT. THE ISSUE IS CONSIDERED A REPORTABLE EVENT BECAUSE IT COULD POTENTIALLY IMPACT THE PATIENT SAFETY DURING VENTILATION SINCE MEDICAL PERSONNEL MAY NOT BE VISUALLY ALERTED AS INTENDED/NEEDED (HOWEVER AUDIBLE ALARMS ARE WORKING). IN AGREEMENT WITH THE FDA, UDI NUMBERS (FIELD D4 IN THIS FORM) ARE ONLY PROVIDED FOR INCIDENTS THAT HAVE BEEN INITIALLY REPORTED BY HAMILTON MEDICAL AG SINCE OCTOBER 1ST, 2023.

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION:ALARM BOARD FAILURE. SOME LED LIGHTS.

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION:ALARM BOARD FAILURE. SOME LEDS LIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2224727 HAMILTON-G5 HAMILTON-G5 VENTILATOR CBK HAMILTON MEDICAL AG 07630002800013

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown