BEUDAMED
    FDA Adverse Event Other Summary report: N

    ENTERALITE INFINITY ENTERAL PUMP

    MDR report key: 2140515 · Received June 21, 2011

    Report

    Report Number
    MW5021104
    Event Type
    Other
    Date Received
    June 21, 2011
    Date of Event
    June 18, 2011
    Report Date
    June 21, 2011
    Manufacturer
    ZYVEK
    Product Code
    LZH
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PUMP ALARMING ERROR CODE 13. COMPANY SAYS THIS IS A MOTOR FAILURE - NEEDS TO BE RETURNED TO THEM; 16TH PUMP WITH THIS CODE SINCE LATE (B)(6) (PUMPS WERE PURCHASED AND PUT INTO SERVICE (B)(6) 2010).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTERALITE INFINITY ENTERAL PUMP ENTERAL FEEDING PUMP LZH ZYVEK

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR