BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ SCHANNEL 3.01

    MDR report key: 3912291 · Received May 13, 2014

    Report

    Report Number
    9615050-2014-03389
    Event Type
    Malfunction
    Date Received
    May 13, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 15, 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
    HI, US
    Reporter Occupation
    OTHER

    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 2 (UIC2) WHICH CAUSED CORRUPT RANDOM ACCESS MEMORY (RAM) DATA. 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. THE DEVICE WAS RETURNED TO THE BIOMED DEPT FOR AN UNSPECIFIED REASON. NO TRACKING INFO WAS PROVIDED; THEREFORE, SPECIFIC PT INFO, PUMP PROGRAMMING, OR EVENT DETAILS WERE NOT AVAILABLE. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS OR DELAYS IN CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. DURING TESTING AT THE USER FACILITY, THE DEVICE ALARMED WITH A WHITESCREEN ERROR. NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285562 SYMBIQ SCHANNEL 3.01 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK