BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE BELMONT RAPID INFUSER

    MDR report key: 7986912 · Received October 19, 2018

    Report

    Report Number
    1219702-2018-00038
    Event Type
    Malfunction
    Date Received
    October 19, 2018
    Date of Event
    September 21, 2018
    Report Date
    October 19, 2018
    Manufacturer
    BELMONT INSTRUMENT LLC
    Product Code
    LGZ
    UDI-DI
    00896128002756
    PMA / PMN Number
    K141654
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR INVESTIGATION AND WAS TESTED USING OUR STANDARD OPERATING PROCEDURES. UPON RECEIPT, THE DISPLAY DID NOT FUNCTION PROPERLY DUE TO FLUID CONTAMINATION ON THE COMPUTER BOARD. AS FLUID CONTAMINATION MAY DAMAGE INTERNAL COMPONENTS, THE SERVICE AND PREVENTIVE MAINTENANCE SCHEDULE OUTLINED IN THE OPERATOR'S MANUAL INSTRUCTS THE USER TO CHECK THE UNIT SEALS EVERY SIX MONTHS. THE FOLLOWING INSTRUCTIONS ARE PROVIDED: "INSPECT THE SEAL AROUND THE UNIT TO MAKE CERTAIN IT IS IN GOOD CONDITION. CHECK ALSO THE SEAL AROUND THE TOUCH SCREEN AND CERAMIC DISKS. USE DOW CORNING 732 MULTIPURPOSE RTV SEALANT OR EQUIVALENT IF NEEDED TO MAINTAIN FLUID RESISTANCE." IT WAS REPORTED THAT THERE WAS NO INJURY TO THE PATIENT.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE DISPLAY STOPPED WORKING DURING A PROCEDURE. IT WAS REPORTED THAT THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    827330 THE BELMONT RAPID INFUSER THERMAL INFUSION FLUID WARMER LGZ BELMONT INSTRUMENT LLC RI-2 00896128002756

    Patients

    Seq Age Sex Outcome Treatment
    1