BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERALITE INFINITY ENTERAL FEEDING PUMP

    MDR report key: 3101617 · Received April 30, 2013

    Report

    Report Number
    1722139-2013-00596
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    February 8, 2013
    Report Date
    April 9, 2013
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    LZH
    PMA / PMN Number
    K031199
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    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"). ALL ALARMS HAVE BEEN CHECKED AND WORK PROPERLY. COMPLAINT COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    CUSTOMER STATES THAT THE PUMP DOES NOT ALARM AND IT KEEPS RUNNING WITH NO FOOD DURING TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188737 ENTERALITE INFINITY ENTERAL FEEDING PUMP LZH MOOG MEDICAL DEVICES GROUP INFINITY PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1