BEUDAMED
    FDA Adverse Event Summary report: N

    ORANGE INFINITY EFP

    MDR report key: 3981344 · Received July 23, 2014

    Report

    Report Number
    1722139-2014-00122
    Date Received
    July 23, 2014
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    LZH
    PMA / PMN Number
    K981816
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS TESTED REPEATEDLY FOR OVER-RUN AND ALARMED CORRECTLY EACH TIME. UNABLE TO CONFIRM COMPLAINT.

    Description of Event or Problem · 1

    INFO INDICATES THAT PUMP CONTINUED TO FUNCTION AFTER FOOD WAS GONE. THERE WAS NO ALARM INDICATING AIR IN THE LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432506 ORANGE INFINITY EFP ENTERAL FEEDING PUMP LZH MOOG MEDICAL DEVICES GROUP EFP

    Patients

    Seq Age Sex Outcome Treatment
    1 5 MO