BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE BELMONT RAPID INFUSER, RI-2

    MDR report key: 19583181 · Received June 21, 2024

    Report

    Report Number
    1219702-2024-00028
    Event Type
    Malfunction
    Date Received
    June 21, 2024
    Date of Event
    April 26, 2024
    Report Date
    August 15, 2024
    Manufacturer
    BELMONT MEDICAL TECHNOLOGIES
    Product Code
    LGZ
    UDI-DI
    10896128002630
    PMA / PMN Number
    K091855
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS EXTENSIVELY TESTED ON SITE FOR PROPER FUNCTIONALITY, AND IT WAS FOUND THE DEVICE FUNCTIONED AS DESIGNED. THE PRESSURE MEASUREMENT, FLOW REGULATION, AIR DETECTION, AIR REMOVAL AND ALARM FUNCTIONALITY WERE ALL TESTED WITH NO PROBLEMS IDENTIFIED. A POSSIBLE CAUSE OF THE DISPLAY REMAINING BLACK IS THE POWER SWITCH NOT BEING FULLY ENGAGED. NO DEVICE MALFUNCTION COULD BE VERIFIED. THE DEVICE HISTORY WAS REVIEWED, AND NO OTHER ISSUES WERE IDENTIFIED. NO DEVICE MALFUNCTION COULD BE VERIFIED, AND THE ROOT CAUSE COULD NOT BE DETERMINED. BELMONT WILL CONTINUE TO MONITOR THIS TYPE OF INCIDENT CLOSELY AND TAKE FURTHER CORRECTIVE AND PREVENTIVE ACTIONS IF REQUIRED.

    Additional Manufacturer Narrative · 0

    THE INTERNAL COMPLAINT FILE # (B)(4) HAVE BEEN LOGGED FOR THIS INCIDENT FOR TRACEABILITY. THE DEVICE INVOLVED IN THE INCIDENT WAS NOT RETURNED TO BELMONT FOR INVESTIGATION. BELMONT WAS INFORMED ABOUT THIS INCIDENT, BY OUR DISTRIBUTOR MEDIQ SUISSE AG ON 23 MAY2024. BELMONT REVIEWED THE USER INCIDENT REPORT FROM SWISSMEDIC AND NOTE THAT THE USER INDICATES THAT BELMONT WAS INFORMED OF THIS INCIDENT ON 29 APR 2024, THIS IS NOT THE CASE. AFTER INVESTIGATION, IT IS CLEAR THAT THE USER CALLED MEDIQ SUISSE AG AROUND THE TIME OF THE ALLEGED INCIDENT AND MEDIQ SUISSE INFORMED THE USER THAT THE ALLEGED INCIDENT MIGHT BE BECAUSE THE MAIN SWITCH HAS NOT BEEN SWITCHED ON PROPERLY AND THAT THEY SHOULD TRY TO REPEAT/REPLICATE IT. THEY WERE NOT ABLE TO REPLICATE, THE MACHINE WORKED WELL. FROM THAT POINT MEDIQ SUISSE DID NOT HEAR ANYTHING MORE FROM THE HOSPITAL. MEDIQ SUISSE WERE NOT INFORMED THAT THE USER HAVE SUBMITTED A SERIOUS INCIDENT MESSAGE TO SWISSMEDIC, UNTIL THEY RECEIVED IT FROM SWISSMEDIC ON MAY 21ST. MEDIQ SUISSE SUBSEQUENTLY INFORMED BELMONT ON 23 MAY 2024 AND WE HAVE REQUESTED THAT THE RI-2 INVOLVED IN THE INCIDENT BE RETURNED FOR INVESTIGATION. IN THE EVENT OF:"LOW BATTERY", THE SYSTEM WILL DISPLAY "BATT LOW" MESSAGE MESSAGE AND SOUND AN AUDIBLE ALARM. THE SYSTEM SHOULD BE PLUGGED INTO AN AC OUTLET TO CONTINUE OPERATION AND CHARGE THE BATTERY. THE OPERATOR ACTION AS,"IF LOW BATTERY DISPLAYED WHILE THE SYSTEM IS CONNECTED TO AC POWER, ONE OF THE COMPONENTS MAY BE DEFECTIVE. SERVICE MACHINE. IF BATTERY IS COMPLETELY DISCHARGED, TURN THE AC POWER OFF, PLUG THE SYSTEM INTO AN AC OUTLET TO RECHARGE THE BATTERY. WAIT FOR AT LEAST 30 SECONDS BEFORE TURNING THE SYSTEM ON ". TO DATE WE HAVE NOT RECEIVED ANY ADDITIONAL INFORMATION, OR THE DEVICE FROM THE USER FACILITY. WITHOUT RESULTS OF THE DEVICE INVESTIGATION, NO CONCLUSIONS CAN BE DRAWN. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION BECOMES AVAILABLE AND THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    BELMONT'S SWISS DISTRIBUTOR REPORTED FOLLOWING: USE IN THE CONTEXT OF A MASS HEMORRHAGE AFTER THE SET WAS INSERTED CORRECTLY, THE POWER BUTTON WAS PRESSED. HOWEVER, THE DISPLAY REMAINED BLACK. USE OF THE DEVICE WAS THEREFORE IMPOSSIBLE. AFTER A SHORT CLARIFICATION WITH THE MEDICAL TECHNOLOGY DEPARTMENT, THE DEVICE WORKED AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221493 THE BELMONT RAPID INFUSER, RI-2 WARMER, INFUSION FLUID LGZ BELMONT MEDICAL TECHNOLOGIES 10896128002630

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown