BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERALITE INFINITY ENTERAL FEEDING PUMP

    MDR report key: 2961537 · Received January 17, 2013

    Report

    Report Number
    1722139-2013-00059
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Report Date
    December 27, 2012
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    LZH
    PMA / PMN Number
    K031199
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FOUND THAT THE DIODE D7 WAS DETERMINED TO BE LEAKY AND WAS OUT OF THE SPEC. NEW PCB BOARD WAS REPLACED TO SOLVE THE ISSUE.

    Description of Event or Problem · 1

    INFO RECEIVED INDICATES THAT PUMP FAILS DIODE TEST WHICH IS THE CAUSE OF THE ERROR CODE 13.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26889 ENTERALITE INFINITY ENTERAL FEEDING PUMP LZH MOOG MEDICAL DEVICES GROUP INFINITY

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR ELECARE