BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ DUAL CHANNEL

    MDR report key: 3955435 · Received June 12, 2014

    Report

    Report Number
    9615050-2014-03960
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 19, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K110901
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION FOUND THE DEVICE ALARMED WITH A S233 (OVERTEMPERATURE-PSC) MALFUNCTION ALARM CODE. FURTHER TESTING NOTED THE FAN WAS NOT ROTATING AS EXPECTED DURING THE BATTERY CHARGE CYCLE. THE PROBABLE CAUSE FOR THE OVERHEATING WAS A BROKEN FAN. THE CAUSE OF THE BROKEN FAN WAS SUPPLIER HANDLING. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    DURING TESTING AT THE USER FACILITY A REVIEW OF THE DEVICE HISTORY INDICATED A S233 (OVERTEMPERATURE-PSC) MALFUNCTION ALARM CODE. THE PUMP WAS RETURNED TO THE BIOMEDICAL DEPARTMENT FOR AN UNSPECIFIED REASON. NO INFORMATION WAS PROVIDED; THEREFORE, SPECIFIC PATIENT INFORMATION, PUMP PROGRAMMING, OR EVENT DETAILS WERE NOT AVAILABLE. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346671 SYMBIQ DUAL CHANNEL 80FRN FRN HOSPIRA COSTA RICA LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1