BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERALITE INFINITY ENTERAL FEEDING PUMP

    MDR report key: 2974568 · Received January 29, 2013

    Report

    Report Number
    1722139-2013-00115
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Date of Event
    January 11, 2013
    Report Date
    January 16, 2013
    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
    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 DOES: ALARMING "DOSE DONE"). ALL ALARMS HAVE BEEN CHECKED AND WORK PROPERLY. COMPLAINT COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    INFORMATION RECEIVED INDICATES THE PUMP DOES NOT STOP OR ALARM WHEN THE BAG IS EMPTY. THERE IS NO PATIENT INJURY. CUSTOMER IS UNWILLING AND UNABLE TO PROVIDE ANY PATIENT INFORMATION OR ADDITIONAL INFORMATION REGARDING TO PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39772 ENTERALITE INFINITY ENTERAL FEEDING PUMP LZH MOOG MEDICAL DEVICES GROUP SMALL VOLUME INFINI

    Patients

    Seq Age Sex Outcome Treatment
    1