BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERALITE INFINITY ENTERAL FEEDING PUMP

    MDR report key: 2796235 · Received October 1, 2012

    Report

    Report Number
    1722139-2012-00977
    Event Type
    Malfunction
    Date Received
    October 1, 2012
    Date of Event
    August 15, 2012
    Report Date
    September 20, 2012
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    LZH
    PMA / PMN Number
    K031199
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CUSTOMER STATES THAT THE PUMP IS RUNNING, SHOWS ALL THE PROPER SYMBOLS, BUT FLUID DOES NOT FLOW OR GET DISPENSED. THE EVENT FOUND DURING TESTING. RATE: 500 DOSE: 20 MEDICATION OR FOOD: 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