BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-G5

    MDR report key: 16476654 · Received March 3, 2023

    Report

    Report Number
    3001421318-2023-00447
    Event Type
    Malfunction
    Date Received
    March 3, 2023
    Date of Event
    December 12, 2022
    Report Date
    April 3, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002800013
    PMA / PMN Number
    K193228
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DETAILED INVESTIGATION WAS PERFORMED BY AN EXPERT FROM THE TECHNICAL SERVICE: SINCE THE COMPLAINT IN QUESTION WAS SUBMITTED TO HAMILTON MEDICAL AG MORE THAN 3 YEARS AGO, NO ATTEMPTS WILL BE PERFORMED TO OBTAIN ADDITIONAL INFORMATION. NO FURTHER INVESTIGATION OR CORRECTION WILL BE PERFORMED EXCEPT THOSE MENTIONED ABOVE. IN FUTURE HAMILTON MEDICAL AG WILL REPORT AN EVENT SIMILAR TO THIS ISSUE AS IT WILL BE DEEMED A REPORTABLE EVENT. THE ALLEGATION IN THIS COMPLAINT WAS CONFIRMED TO BE A COMPLAINT. WITH THIS INVESTIGATION IT HAS BEEN CONFIRMED THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS AT THE TIME OF THE EVENT WHILE THE VENTILATOR WAS PREPARED FOR TREATMENT. THE ROOT CAUSE WAS DETERMINED TO BE A DEFECTIVE POWER SUPPLY. IN CONSEQUENCE (CORRECTION) THE POWER MANAGEMENT SYSTEM WAS REPLACED. THERE WAS NO PATIENT OR USER HARM REPORTED.

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG REQUESTED FURTHER INFORMATION. INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION: "WILL NOT RECEIVE AC POWER, REPLACED BOARD FORM 3210510, FUNCTION CHECK PASS AFTER BOARD REPLACEMENT " INCIDENT OCCURRED BEFORE START-UP, NO PATIENT WAS INVOLVED.

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION: "WILL NOT RECEIVE AC POWER, REPLACED BOARD FORM 3210510, FUNCTION CHECK PASS AFTER BOARD REPLACEMENT " INCIDENT OCCURRED BEFORE START-UP, NO PATIENT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1993725 HAMILTON-G5 HAMILTON-G5 VENTILATOR CBK HAMILTON MEDICAL AG HAMILTON-G5 07630002800013

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown