BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ 3.13 DUAL CHA

    MDR report key: 3882679 · Received April 10, 2014

    Report

    Report Number
    9615050-2014-02579
    Event Type
    Malfunction
    Date Received
    April 10, 2014
    Date of Event
    March 1, 2014
    Report Date
    March 11, 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
    MD, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER PERFORMED TESTING AND INVESTIGATION AT THE USER FACILITY. DURING TESTING AT THE USER FACILITY, THE DEVICE HISTORY INDICATED A S233 (OVERTEMPERATURE-PSC) MALFUNCTION ALARM CODE AND A BROKEN FAN WAS NOTED. THE PROBABLE CAUSE WAS DUE TO A BROKEN FAN. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DEVICE ALARMED WITH A S233 (OVERTEMPERATURE-PSC) MALFUNCTION ALARM CODE. THE PUMP WAS RETURNED TO THE BIOMEDICAL DEPARTMENT FOR AN UNSPECIFIED REASON. NO INFO WAS PROVIDED; THEREFORE, SPECIFIC PT INFO, PUMP PROGRAMMING, OR EVENT DETAILS WERE NOT AVAILABLE. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. DURING TESTING AT THE USER FACILITY, THE DEVICE HISTORY INDICATED A S233 (OVERTEMPERATURE-PSC) MALFUNCTION ALARM CODE AND A BROKEN FAN WAS NOTED. NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216389 SYMBIQ 3.13 DUAL CHA 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK