BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERALITE INFINITY ENTERAL FEEDING PUMP

    MDR report key: 2842192 · Received October 22, 2012

    Report

    Report Number
    1722139-2012-01067
    Event Type
    Malfunction
    Date Received
    October 22, 2012
    Date of Event
    October 2, 2012
    Report Date
    October 5, 2012
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    LZH
    PMA / PMN Number
    K031199
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PUMP WAS TESTED FOR ACCURACY SEVERAL TIMES, USING WATER. EACH TIME PUMP DELIVERED AMOUNT WITHIN SPECIFICATION ((B)(4)). COMPLAINT COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    CUSTOMER STATES THAT PUMP DELIVERED 12 ML DURING TESTING. RATE, DOSE, AND FOOD ARE 500 ML/HR, 10 ML, AND WATER.

    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