BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ SINGLE CHANNE

    MDR report key: 3963329 · Received June 19, 2014

    Report

    Report Number
    9615050-2014-04085
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    January 1, 2014
    Report Date
    May 28, 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
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER PERFORMED TESTING AND INVESTIGATION AT THE USER FACILITY. DURING TESTING, THE DEVICE FAN HAD AN ABNORMAL NOISE ON POWER UP. THE CUSTOMER REPORTED ERROR CODE S233 (OVER TEMPERATURE) WAS NOTED IN THE DEVICE HISTORY. THE PROBABLE CAUSE OF THE ERROR CODE S233 AND ABNORMAL NOISE WAS DUE TO THE FAN ASSEMBLY NOT WORKING PROPERLY. 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 THE DEVICE ALARMED WITH ERROR CODE S233 (OVER TEMPERATURE) AND THE FAN WAS NOISY. THE DEVICE WAS RETURNED TO THE BIOMEDICAL 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 FAN PRODUCED AN ABNORMAL NOISE ON POWER UP AND A S233 ERROR CODE WAS NOTED IN THE DEVICE HISTORY. NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359166 SYMBIQ SINGLE CHANNE 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK