BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERALITE INFINITY ENTERAL FEEDING PUMP

    MDR report key: 2133494 · Received June 14, 2011

    Report

    Report Number
    MW5021016
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Date of Event
    June 13, 2011
    Report Date
    June 14, 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

    ERROR 13 WITH PUMP. MFR INDICATES THIS IS A PUMP MOTOR FAILURE AND REQUIRES IT TO BE SENT BACK TO THEM FOR REPAIR THIS IS #15 SINCE LATE (B)(6) 2011.

    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 17 YR