BEUDAMED
    FDA Adverse Event Other Summary report: N

    SIGMA 8000

    MDR report key: 555087 · Received April 27, 2004

    Report

    Report Number
    1314492-2004-00003
    Event Type
    Other
    Date Received
    April 27, 2004
    Date of Event
    March 22, 2004
    Report Date
    April 23, 2004
    Manufacturer
    SIGMA INTL.
    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

    TWO EACH SIGMA INFUSION PUMPS WERE SENT TO BIOMEDICAL ENGINEERING WITH SIGNS OF BURNING ON PUMP TUBE RELEASE LEVERS ON LOWER LEFT OF PUMPS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other