BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFECARE

    MDR report key: 2933200 · Received December 31, 2012

    Report

    Report Number
    2933200
    Event Type
    Malfunction
    Date Received
    December 31, 2012
    Date of Event
    November 11, 2012
    Report Date
    December 26, 2012
    Manufacturer
    HOSPIRA, INC.
    Product Code
    MEA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    PCA (PATIENT-CONTROLLED ANALGESIA) MACHINE BEGAN ALARMING AT 0100 WITH PCA MALFUNCTION MESSAGE AND THE NUMBER 632-0000. THERE WAS NO HARM DONE TO PATIENT. NEW PCA MACHINE REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFECARE PUMP, INFUSION, PCA MEA HOSPIRA, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR