BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERALITE INFINITY ENTERAL FEEDING PUMP

    MDR report key: 3881262 · Received February 18, 2014

    Report

    Report Number
    1722139-2014-00048
    Event Type
    Malfunction
    Date Received
    February 18, 2014
    Date of Event
    January 24, 2014
    Report Date
    January 24, 2014
    Manufacturer
    MOOG MED DEVICES GROUP
    Product Code
    LZH
    PMA / PMN Number
    K981816
    Removal / Correction Number
    Z-0294-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FOUND THAT PUMP HAD NO ERROR CODE 13 IN PUMP'S HISTORY, BUT FAILED DIODE D7 TEST. NEW PCB BOARD WAS REPLACED TO SOLVE THE ISSUE. REFERENCE RECALL #: Z-0294-2013.

    Description of Event or Problem · 1

    INFO RECEIVED INDICATES THAT PUMP EXPERIENCES ERROR CODE 13. THERE WERE NO RATE, DOSAGE, OR PT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101228 ENTERALITE INFINITY ENTERAL FEEDING PUMP LZH MOOG MED DEVICES GROUP INFINITY PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1