BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ SINGLE CHANNEL

    MDR report key: 4173270 · Received October 10, 2014

    Report

    Report Number
    9615050-2014-05587
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    January 1, 2014
    Report Date
    September 22, 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 DEVICE IS MECHANISM 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 THE DEVICE ALARMED WITH S321 (MOTOR ERROR - PMC, LEFT) MALFUNCTION ALARM CODE. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPARTMENT WITH AN UNSIGNED NOTE THAT STATED, "S321 AND S320 MALFUNCTION ALARM, UNABLE TO RESET CHANNEL". NO SPECIFIC PT INFO, PUMP PROGRAMMING, OR EVENT DETAILS WERE PROVIDED. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. DURING TESTING AT THE USER FACILITY, ON POWER UP, THE DEVICE ALARMED WITH A S321 (MOTOR ERROR - PMC, LEFT) AND S320 (HOMING TIMEOUT, LEFT) MALFUNCTION ALARM CODE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643107 SYMBIQ SINGLE CHANNEL 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK