BEUDAMED
    FDA Adverse Event Other Summary report: N

    SIGMA 8000+

    MDR report key: 587611 · Received May 24, 2004

    Report

    Report Number
    1314492--02004
    Event Type
    Other
    Date Received
    May 24, 2004
    Date of Event
    October 1, 2003
    Report Date
    May 17, 2004
    Manufacturer
    SIGMA INTERNATIONAL
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    SIGMA 8000 INFUSION PUMP CAUGHT FIRE ON LOWER SENSOR ASSEMBLY DAMAGING SENSOR, FRONT CASE, AND LOWER PPUMP CHANNEL. PUM RETURNED TO MANUFACTURER FOR EVALUATION AND REPAIR 10/2003.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA 8000+ PROGRAMMABLE INFUSION PUMP FRN SIGMA INTERNATIONAL 8000+ *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other