BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ SCHANNEL 3.01

    MDR report key: 3905851 · Received May 29, 2014

    Report

    Report Number
    9615050-2014-03706
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    January 1, 2014
    Report Date
    April 30, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K110901
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION FOUND AT POWER UP, THE DEVICE DISPLAYED A WHITESCREEN ERROR AND THE DEVICE SOUNDED AN AUDIBLE ALARM FROM THE SECONDARY BEEPER. THIS WAS DUE TO A DEPLETED BACK UP BATTERY ON THE USER INTERFACE CONTROLLER (UIC). THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A WHITESCREEN ERROR. NO SPECIFIC PT INFO, PUMP PROGRAMMING, OR EVENT DETAILS WERE AVAILABLE. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS OR DELAYS IN CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317403 SYMBIQ SCHANNEL 3.01 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK