BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE BELMONT RAPID INFUSER

    MDR report key: 13269080 · Received January 17, 2022

    Report

    Report Number
    1219702-2022-00002
    Event Type
    Malfunction
    Date Received
    January 17, 2022
    Date of Event
    November 16, 2021
    Report Date
    January 17, 2022
    Manufacturer
    BELMONT MEDICAL TECHNOLOGIES
    Product Code
    LGZ
    UDI-DI
    00896128002817
    PMA / PMN Number
    K141654
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE RAPID INFUSER, RI-2 INVOLVED IN THE INCIDENT HAS BEEN RETURNED TO BELMONT MEDICAL TECHNOLOGIES UK FOR EVALUATION. IT WAS REPORTED THAT THE INCIDENT OCCURRED DURING ROUTINE TESTS IN THE WORKSHOP; THERE WAS NO PATIENT INVOLVED. THE OPERATOR'S MANUAL INSTRUCTS THE USER TO PLUG THE SYSTEM POWER CORD INTO A DEDICATED-GROUNDED, 3-PRONG, MINIMUM 10 AMP, AC RECEPTACLE, AS THE SYSTEM CAN DRAW A SIGNIFICANT FRACTION OF THE CIRCUIT CAPABILITIES AND THEREFORE CAUSE THE THEATRE BREAKERS TO TRIP WHEN THE LINE IS SHARED. IT IS UNCLEAR WHETHER THE DEVICE WAS PLUGGED INTO A DEDICATED OUTLET. WITHOUT RESULTS OF THE DEVICE INVESTIGATION, IT IS NOT POSSIBLE TO ESTABLISH A ROOT CAUSE AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    BELMONT MEDICAL TECHNOLOGIES RECEIVED THE FOLLOWING REPORT (INCIDENT NUMBER (B)(4)) FROM (B)(6) IN THE UK: "DEVICE TRIPPED OUT THE MAINS AC CONTACT BREAKER IN EMERGENCY OPERATING THEATRE." IT WAS REPORTED THAT THE INCIDENT OCCURRED DURING ROUTINE TESTS IN THE WORKSHOP WITH NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    807140 THE BELMONT RAPID INFUSER THERMAL INFUSION FLUID WARMER LGZ BELMONT MEDICAL TECHNOLOGIES RI-2 00896128002817

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown