BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPANION PUMP

    MDR report key: 2062305 · Received March 18, 2011

    Report

    Report Number
    1527460-2011-00021
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Manufacturer
    ABBOTT NUTRITION
    Product Code
    LZH
    PMA / PMN Number
    K873119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE TESTING AND INVESTIGATION RESULTS IDENTIFIED AN UNDER-DELIVERY AND A CRACKED OR BROKEN ADAPTER BRACKET (INTERNAL DAMAGE). THE FRONT PUMP CASE WAS BROKEN, AND THE BATTERY ACCESS PANEL, RELEASE LEVER, AND DC JACK WERE DAMAGED. ABBOTT NUTRITION STANDARD PROCEDURE INCLUDES ATTEMPTING TO OBTAIN ALL REQUIRED INFO FROM THE SOURCE.

    Description of Event or Problem · 1

    THE DEVICE EVAL IDENTIFIED REPORTABLE MALFUNCTIONS, UNDER-DELIVERY AND CRACKED OR BROKEN ADAPTER BRACKET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPANION PUMP LZH PUMP, INFUSION, ENTERAL LZH ABBOTT NUTRITION 00084

    Patients

    Seq Age Sex Outcome Treatment
    1