BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ SINGLE CHANNEL

    MDR report key: 3802926 · Received February 21, 2014

    Report

    Report Number
    9615050-2014-01440
    Event Type
    Malfunction
    Date Received
    February 21, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 24, 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
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER PERFORMED INITIAL TESTING AND INVESTIGATION AT THE USER FACILITY. THE DEVICE DID NOT PASS THE POWER UP TEST AND CONFIRMED THE DEVICE ALARMED WITH A S321 (MOTOR ERROR-PMC, LEFT MALFUNCTION ALARM CODE. THE PROBABLE CAUSE OF THE S321 MALFUNCTION ALARM CODE WAS A BROKEN MECHANISM ASSEMBLY. THE DEVICE MECHANISM HAS BEEN RECEIVED INVESTIGATION IS NOT COMPLETE. 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 DEVICE ALARMED WITH A S321 (MOTOR ERROR-PMC, LEFT) MALFUNCTION ALARM CODE. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPARTMENT WITH A REPORT OF THE DEVICE ALARMING WITH A S321 MALFUNCTION ALARM CODE. 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 AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. DURING TESTING AT THE USER FACILITY THE DEVICE ALARMED WITH A S321 (MOTOR ERROR-PMC, LEFT) MALFUNCTION ALARM CODE. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108993 SYMBIQ SINGLE CHANNEL 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA