BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ

    MDR report key: 2223304 · Received August 9, 2011

    Report

    Report Number
    2223304
    Event Type
    Malfunction
    Date Received
    August 9, 2011
    Date of Event
    July 5, 2011
    Report Date
    August 9, 2011
    Manufacturer
    HOSPIRA
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    DURING PM TESTING, PUMP DISPLAY A WHITE SCREEN, ACTIVATED SECONDARY ALARM AND SHOWED NVRAM ACCESS ERROR.======================MANUFACTURER RESPONSE FOR GENERAL PURPOSE IV PUMP, SYMBIQ (PER SITE REPORTER)======================TESTING AND INVESTIGATION CONFIRMED THE COMPLAINT. THE DEVICE DISPLAYED A WHITE SCREEN SOFTWARE ERROR DURING ANALYSIS. THE PROBLEM WAS CAUSED BY CORRUPTED SOFTWARE. MANUFACTURER RE-LOADED THE SOFTWARE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *