BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERALITE INFINITY ENTERAL FEEDING PUMP

    MDR report key: 2873493 · Received November 15, 2012

    Report

    Report Number
    1722139-2012-01173
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    October 1, 2012
    Report Date
    November 7, 2012
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    LZH
    PMA / PMN Number
    K031199
    Removal / Correction Number
    TBD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 SPECIFICATION. NEW PCB BOARD WAS REPLACED TO SOLVE THE ISSUE.

    Description of Event or Problem · 1

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

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1