BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGMA

    MDR report key: 1843441 · Received August 26, 2010

    Report

    Report Number
    1843441
    Event Type
    Malfunction
    Date Received
    August 26, 2010
    Date of Event
    August 25, 2010
    Report Date
    August 26, 2010
    Manufacturer
    SIGMA
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    NURSE ATTEMPTED TO START IV FLUIDS BY PROGRAMMING PUMP. PUMP WAS BEEPING AND FLASHING THE FOLLOWING MESSAGE: PUMP MALFUNCTION. NURSE TURNED OFF PUMP AND TRIED TO REPROGRAM; PUMP MALFUNCTION MESSAGE APPEARED AGAIN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *