BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 15433707 · Received September 15, 2022

    Report

    Report Number
    3001421318-2022-00012
    Event Type
    Malfunction
    Date Received
    September 15, 2022
    Date of Event
    August 17, 2022
    Report Date
    September 13, 2022
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002800747
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    FIRST INSIGHTS: DEVICE WAS STARTED ON (B)(6) 2022 AT 23:31:17 WITH HI FLOW MODE AT 23:53:37 THE FIRST CHECK PATIENT INTERFACE IS DEPOSITED FURTHER CHECK PATIENT INTERFACES FOLLOW UNTIL TE 232005 OCCURS AT 00:05:15. FURTHER CHECK PATIENT INTERFACES ARE STORED AND THE ALARM SILENCE BUTTON IS ACTIVATED SEVERAL TIMES AND OXYGEN VALUES ARE ADJUSTED BY THE USER ON (B)(6) 2022 AT 00:55:44 THE DEVICE IS PUT INTO STANDBY. CONCLUSION: THE TE 232005 WAS TRIGGERED BECAUSE THE BLOWER OPERATING TEMPERATURE WAS OVER >92 DEGREES DURING HI FLOW THERAPY. THE BLOWER IS A 1ST GENERATION BLOWER WHICH *DOES NOT HAVE A HEAT SINK". THE BLOWER IS THE ORIGINAL BLOWER THAT WAS INSTALLED IN PRODUCTION AT THE TIME THE TE 232005 WAS CANCELED AFTER THE BLOWERTEMP. HAS COOLED DOWN, THE ALARM WAS NO LONGER TRIGGERED AFTER THIS EVENT. CHECK PATIENT INTERFACE ALARMS HAVE INCREASED. CAUSE: DUE TO THE FREQUENT CHECK PATIENT INTERFACE ALARMS, THE BLOWER WAS MORE HEAVILY LOADED AND HAD TO REACH THE SET FLOW MORE OFTEN DUE TO THE INCREASED LOAD, THE BLOWER TEMPERATURE INCREASED UNTIL THE SAFETY ALARM TE 232005 WAS TRIGGERED. SINCE THE BLOWER DOES NOT HAVE AN EXTERNAL HEAT SINK, THE TEMPERATURE LIMIT FOR THE TE232005'S TRIGGER WAS EXCEEDED MORE QUICKLY AND EASILY. THE CHECK PATIENT INTERFACE ALARMS ARE PROBABLY CAUSED BY THE PATIENT OR BY A BLOCKAGE IN THE INSPIRATORY TUBE. COUNTER-PRESSURE FROM THE PATIENT CANNOT BE RULED OUT EITHER. FURTHER INSTRUCTIONS: THE USER SHOULD REACT AS SOON AS THE CHECK PATIENT INTERFACE ALARMS APPEAR AND, IF NECESSARY, ADJUST THE SETTINGS, ALSO CHECK THE INSPIRATORY HOSE. BACK PRESSURE FROM THE PATIENT SHOULD BE AVOIDED. THE BLOWER CAN CONTINUE TO BE USED BECAUSE NO MORE TECHNICAL PROBLEMS HAVE OCCURRED, THE BLOWER IS NOT DEFECTIVE BECAUSE NO ERROR MESSAGE APPEARS THE NEXT TIME IT IS STARTED. THE INCREASED TEMPERATURE OF THE BLOWER CAN AFFECT THE SERVICE LIFE! HAMILTON MEDICAL AG REFERENCE NR: (B)(4).

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: THE HOSPITAL STAFF REPLACED THIS C1 WITH ANOTHER VENTILATOR BECAUSE TE232005 OCCURRED WHILE USING THIS C1 ON A PATIENT IN HIFLOWO2 MODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222676 HAMILTON MEDICAL AG HAMILTON-C1 CBK HAMILTON MEDICAL AG HAMILTON-C1 07630002800747

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown