BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERALITE INFINITY ENTERAL FEEDING PUMP

    MDR report key: 2935762 · Received January 2, 2013

    Report

    Report Number
    1722139-2013-00005
    Event Type
    Malfunction
    Date Received
    January 2, 2013
    Date of Event
    November 1, 2012
    Report Date
    December 7, 2012
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    LZH
    PMA / PMN Number
    K031199
    Removal / Correction Number
    Z-0294-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    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. (B)(4).

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1454 ENTERALITE INFINITY ENTERAL FEEDING PUMP LZH MOOG MEDICAL DEVICES GROUP INFINITY PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1