BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATROL PUMP

    MDR report key: 1193167 · Received October 7, 2008

    Report

    Report Number
    1527460-2008-00866
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Manufacturer
    ABBOTT NUTRITION
    Product Code
    LZH
    PMA / PMN Number
    K943733
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL CONFIRMED A DAMAGED POWER CORD. AN OPENING IN THE INSULATION OF THE INTERNAL WIRES NEAR THE STRAIN RELIEF WAS VERIFIED. ABBOTT NUTRITION STANDARD PROCEDURE INCLUDES ATTEMPTING TO OBTAIN ALL REQUIRED INFO FROM THE SOURCE.

    Description of Event or Problem · 1

    THE DEVICE EVAL IDENTIFIED A REPORTABLE MALFUNCTION, DAMAGED POWER CORD, UNRELATED TO THE ORIGINAL COMPLAINT, WHICH WAS A NON-REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PATROL PUMP LZH PUMP, INFUSION, ENTERAL LZH ABBOTT NUTRITION 52036

    Patients

    Seq Age Sex Outcome Treatment
    1