BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-G5

    MDR report key: 18028738 · Received October 30, 2023

    Report

    Report Number
    3001421318-2023-03683
    Event Type
    Malfunction
    Date Received
    October 30, 2023
    Date of Event
    October 25, 2023
    Report Date
    January 23, 2025
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002800013
    PMA / PMN Number
    K193228
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    ALARM LAMP BOARD WAS FOUND DEFECTIVE AND REPLACED.

    Additional Manufacturer Narrative · 0

    ALARM LAMP BOARD WAS FOUND DEFECTIVE AND REPLACED. HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4). FOLLOW-UP 1 - CORRECTED INFORMATION: **UDI RELATED DATA QUALITY UPDATES ONLY** FIELD D4 WAS UPDATED WITH FULL UDI INFORMATION AS REQUESTED. UPDATED FIELDS: B4, D1, D4, G3, G6, H2, H4.

    Additional Manufacturer Narrative · 0

    ALARM LAMP BOARD WAS FOUND DEFECTIVE AND REPLACED. ADDITIONAL INFORMATION ADDED IN FOLLOW-UP #2 CER 143499. 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: 159272 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).

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION: RED AND AMBER LEDS ARE NOT LIGHTING UP.

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION: RED AND AMBER LEDS ARE NOT LIGHTING UP.

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION: RED AND AMBER LEDS ARE NOT LIGHTING UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2009368 HAMILTON-G5 HAMILTON-G5 VENTILATOR CBK HAMILTON MEDICAL AG 159002 07630002800013

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown