BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 17486779 · Received August 9, 2023

    Report

    Report Number
    3001421318-2023-02847
    Event Type
    Malfunction
    Date Received
    August 9, 2023
    Date of Event
    July 27, 2023
    Report Date
    August 9, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002800372
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THIS IS A CASE REPORT RECEIVED ON AUGUST 1ST FROM BOMIMED INC (CANADA) RELATED TO THE FOLLOWING : UNIT DISPLAYS PATIENT DISCONNECT ALARM DESPITE PRE-OP CHECKS PASSING AND ALL TESTS PASSING. USER MENTIONED THAT IT REOCCURRED DURING FLOW SENSOR CHECK AS WELL, BUT THEN WAS GONE AFTER ABOUT A MINUTE OF TRYING. ACCORDING TO THE REPORTER, THERE WAS NO PATIENT OR USER OR THIRD PARTY HARMED; THIS ISSUE DID NOT OCCUR DURING VENTILATION. THERE ARE NO INDICATION THAT THE COMPLAINT LEAD TO DEATH, INJURY OR SERIOUS DETERIORATION OF THE HEALTH OF THE PATIENT AND OPERATOR. PRELIMINARY ANALYSIS REVEALED THAT: THIS CASE IS RELATED TO WRONG POSITIVE ALARM "DISCONNECTION" DUE TO THE EXPIRATORY MEMBRANE (MISPLACE OR DEFECTIVE) POTENTIAL ROOT CAUSES COULD BE RELATED TO AN EXPIRATORY VALVE MISPLACE, STICKY OR DEFECT. PROPOSED CORRECTION: CHECK THE CONDITION OF THE EXPIRATORY VALVE SET. IF ANYTHING DEFECTIVE, REPLACE. CHECK WHETHER THE EXPIRATORY VALVE IS AFFECTED BY ANY NEBULIZING AGENT. MAKE SURE THAT THE EXPIRATORY VALVE IS PROPERLY INSTALLED. CHECK WHETHER THERE IS A DISCONNECTION AT THE EXPIRATORY VALVE PERFORM TIGHTNESS TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1587986 HAMILTON MEDICAL AG HAMILTON-G5 CBK HAMILTON MEDICAL AG HAMILTON-G5 07630002800372

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown