BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERALITE INFINITY ENTERAL FEEDING PUMP

    MDR report key: 3823318 · Received February 28, 2014

    Report

    Report Number
    1722139-2014-00054
    Event Type
    Malfunction
    Date Received
    February 28, 2014
    Date of Event
    January 1, 2013
    Report Date
    January 30, 2014
    Manufacturer
    MOOG MED DEVICES GROUP
    Product Code
    LZH
    PMA / PMN Number
    K981816
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LH
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION BY (B)(4) SERVICE CENTER IN (B)(4) FOUND THAT PUMP EVENT LOG HAD ERROR CODE 13. PUMP PCB BOARD WAS REPLACED. THIS MDR IS BEING SUBMITTED BECAUSE THIS DEVICE IS SIMILAR TO A DEVICE MARKETED IN THE UNITED STATES.

    Description of Event or Problem · 1

    INFO RECEIVED FROM (B)(4) SERVICE CENTER IN (B)(4) INDICATES THAT PUMP EXPERIENCES ERROR CODE 13.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124986 ENTERALITE INFINITY ENTERAL FEEDING PUMP LZH MOOG MED DEVICES GROUP FLOCARE PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1