BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERALITE INFINITY ENTERAL FEEDING PUMP

    MDR report key: 2181262 · Received July 21, 2011

    Report

    Report Number
    MW5021484
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    May 31, 2011
    Report Date
    June 1, 2011
    Manufacturer
    ZYVEK
    Product Code
    LZH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PUMP ALARMING ERROR CODE 13 - WHICH PER THE MFR IS A PUMP MOTOR FAILURE CODE THAT MUST BE RETURNED TO THEM FOR SERVICING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR