BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERALITE INFINITY ENTERAL FEEDING PUMP

    MDR report key: 2842194 · Received October 22, 2012

    Report

    Report Number
    1722139-2012-01066
    Event Type
    Malfunction
    Date Received
    October 22, 2012
    Date of Event
    September 10, 2012
    Report Date
    September 24, 2012
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    LZH
    PMA / PMN Number
    K031199
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PUMP HAS BEEN TESTED SEVERAL TIMES USING WATER, AND EACH TIME WHEN BAG WAS EMPTY PUMP STOPPED PUMPING AND ALARMING NO FOOD (OR PUMP FINISH DOSE: ALARMING "DOSE DONE"). COMPLAINT COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    CUSTOMER STATES THAT PUMP DOES NOT STOP WHEN THE BAG IS EMPTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTERALITE INFINITY ENTERAL FEEDING PUMP LZH MOOG MEDICAL DEVICES GROUP INFINITY PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR NEOCATE JR W/PREBIOTICS 400 GM