BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFECARE

    MDR report key: 2161738 · Received July 8, 2011

    Report

    Report Number
    2161738
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    May 31, 2011
    Report Date
    July 2, 2011
    Manufacturer
    HOSPIRA
    Product Code
    MEA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PCA PUMP BEEPING READING, "MALFUNCTION 623/0000".

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR