BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE BELMONT RAPID INFUSER

    MDR report key: 7924464 · Received October 1, 2018

    Report

    Report Number
    1219702-2018-00035
    Event Type
    Malfunction
    Date Received
    October 1, 2018
    Report Date
    October 1, 2018
    Manufacturer
    BELMONT INSTRUMENT LLC
    Product Code
    LGZ
    UDI-DI
    70896128002038
    PMA / PMN Number
    K141654
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DISTRIBUTOR EVALUATED THE DEVICE AND FOUND THAT IT PERFORMED ACCORDING TO SPECIFICATIONS. THE DISTRIBUTOR HAS BEEN CONTACTED FOR ADDITIONAL DETAILS ABOUT THE EVENT AND STATUS OF THE PATIENT. THE HARDWARE DEVICE HAS BEEN RECEIVED BY BELMONT FOR EVALUATION. THE INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WITH ALL ADDITIONAL RELEVANT INFORMATION WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE DISPOSABLE SET WAS DEFORMED FOLLOWING AN OVERHEAT INCIDENT THAT OCCURRED DURING A CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763738 THE BELMONT RAPID INFUSER THERMAL INFUSION FLUID WARMER LGZ BELMONT INSTRUMENT LLC RI-2 70896128002038

    Patients

    Seq Age Sex Outcome Treatment
    1