BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ SCHANNEL 3/01

    MDR report key: 4172258 · Received October 9, 2014

    Report

    Report Number
    9615050-2014-05541
    Event Type
    Malfunction
    Date Received
    October 9, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 19, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED DURING TESTING AT THE USER FACILITY, THE DEVICE ALARMED WITH S321 (MOTOR ERROR-PMC, LEFT), S339 (POWER DOWN ERROR, PMC LEFT), S239 (POWER DOWN ERROR, PSC) AND S208 (CAN BUS ERROR-PSC) MALFUNCTION ALARM CODES. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPARTMENT FROM AN UNKNOWN FLOOR FOR ERROR CODES S321, S339, S239, AND S208. 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
    636914 SYMBIQ SCHANNEL 3/01 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK