BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERALITE INFINITY EFP

    MDR report key: 4161844 · Received July 24, 2014

    Report

    Report Number
    1722139-2014-00127
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    January 12, 2014
    Report Date
    July 24, 2014
    Manufacturer
    MOOG MEDICAL DEVICE GROUP
    Product Code
    LZH
    PMA / PMN Number
    K981816
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS EXAMINED, ALL ALARMS WORKED AS SPECIFIED.

    Description of Event or Problem · 1

    INFORMATION INDICATES PUMP SHUT OFF IN THE MIDDLE OF THE NIGHT WITHOUT ALARMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433102 ENTERALITE INFINITY EFP ENTERAL FEEDING PUMP LZH MOOG MEDICAL DEVICE GROUP EFP

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR