BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATROL PUMP

    MDR report key: 1051657 · Received May 19, 2008

    Report

    Report Number
    1527460-2008-00819
    Event Type
    Malfunction
    Date Received
    May 19, 2008
    Date of Event
    January 1, 2008
    Report Date
    April 21, 2008
    Manufacturer
    ROSS PRODUCTS DIVISION
    Product Code
    LZH
    PMA / PMN Number
    K943733
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ROSS STANDARD PROCEDURE INCLUDES ATTEMPTING TO OBTAIN ALL REQUIRED INFORMATION FROM THE SOURCE.

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED AN UNDERDELIVERY. THE PUMP UNDERDELIVERED BY 40.0% (RATE: 125ML/HOUR). THE PATIENT WAS NOT AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PATROL PUMP LZH PUMPS, INFUSION, ENTERAL LZH ROSS PRODUCTS DIVISION 52034

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR