BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM

    MDR report key: 2489195 · Received February 27, 2012

    Report

    Report Number
    2489195
    Event Type
    Malfunction
    Date Received
    February 27, 2012
    Date of Event
    February 25, 2012
    Report Date
    February 27, 2012
    Manufacturer
    SIGMA
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    SIGMA SPECTRUM PUMP WITH SYSTEM ERROR, PUMP WOULD NOT CONTINUE WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRUM INFUSION PUMP FRN SIGMA * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *