BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERALITE INFINITY

    MDR report key: 1208849 · Received October 21, 2008

    Report

    Report Number
    MW5008708
    Event Type
    Malfunction
    Date Received
    October 21, 2008
    Date of Event
    January 1, 2008
    Report Date
    October 21, 2008
    Manufacturer
    ZEVEK, INC.
    Product Code
    LZH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SINCE BEGINNING OF THE YEAR, OUR COMPANY HAS HAD 15 REPORTED INCIDENCES OF BROKEN LID ON THE ZEVEX ENTERALITE INFINITY PUMP, AS REPORTED BY OUR PATIENTS. OUR PATIENTS USE THESE PUMPS FOR ENTERAL FEEDING AT HOME. THE LIDS ON THESE ZEVEK ENTERALITE INFINITY PUMPS WERE CRACKED OR BROKEN AT THE LATCH IN FRONT, REQUIRING THE LIDS TO BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTERALITE INFINITY ZEVEK INFINITY FEEDING PUMP LZH ZEVEK, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1