BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BODYGUARD

    MDR report key: 5356891 · Received January 11, 2016

    Report

    Report Number
    5356891
    Event Type
    Malfunction
    Date Received
    January 11, 2016
    Date of Event
    October 4, 2014
    Report Date
    November 16, 2015
    Manufacturer
    CME AMERICA, LLC
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CHANNEL 1 PRIMED AND WHEN HIT OK TO INFUSE, PART OF THE SCREEN WAS NOT COMPLETELY ON, SO THE NUMBER TO SHOW CC/HR WAS NOT DISPLAYED AND THE RED LINE THAT CIRCLES TO SHOW PUMPING WAS ONLY A SINGLE SMALL LIGHT. EVEN THOUGH PUMP ON MAIN SCREEN SAID WAS INFUSING, DRIPS COMING OUT WERE SLOW COMPARED TO BEDSIDE PUMP AT A SLOWER RATE. MEDICATION WAS THEN SWITCHED TO CHANNEL 2 ON THIS PUMP AND WORKED ACCORDINGLY. .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17372 BODYGUARD PUMP, INFUSION FRN CME AMERICA, LLC N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR