BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERALITE INFINITY ENTERAL FEEDING PUMP

    MDR report key: 2961530 · Received January 17, 2013

    Report

    Report Number
    1722139-2013-00061
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    December 7, 2012
    Report Date
    December 17, 2012
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    LZH
    PMA / PMN Number
    K031199
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PUMP WAS TESTED WITH WATER USING CUSTOMER'S SETTING, PUMP WAS ABLE TO PRIME AND RUN WITH NO ALARMS. ALL ALARMS HAVE BEEN CHECKED AND WORKED PROPERLY. COMPLAINT COULD NOT BE CONFIRMED. DISPOSABLE SET USED BY CUSTOMER WAS NOT RETURNED FOR EVAL.

    Description of Event or Problem · 1

    CUSTOMER STATES THAT PUMP IS NOT INFUSING ANY WATER AND NOT ALARMING 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
    26800 ENTERALITE INFINITY ENTERAL FEEDING PUMP LZH MOOG MEDICAL DEVICES GROUP INFINITY PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1