BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOSPIRA GEMSTAR

    MDR report key: 1882012 · Received October 22, 2010

    Report

    Report Number
    MW5017892
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    September 13, 2010
    Report Date
    October 11, 2010
    Manufacturer
    HOSPIRA
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    HOSPIRA GEM PCA PUMP WAS HEARD BEEPING REPETITIVELY WITH "CALL" MESSAGE ON DISPLAY; PUMP WAS D/C'D AND REPLACED WITH NEW PUMP. PUMP TO BIOMED; STRESS RELEASE WAS BROKEN OFF FROM BOLUS CORD CONNECTOR - SAME ISSUE WE HAD IN 2009. DATES OF USE: (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: PCA PUMP - PAIN MGMT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOSPIRA GEMSTAR PCA PUMP FRN HOSPIRA 13088-04-02

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR