BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ FRENCH SINGLE

    MDR report key: 3894450 · Received April 25, 2014

    Report

    Report Number
    9615050-2014-03002
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Date of Event
    March 7, 2014
    Report Date
    March 27, 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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE MECHANISM IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. 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 THAT DURING PREVENTIVE MAINTENANCE TESTING AT THE USER FACILITY, A S321 (MOTOR ERROR-PCM, LEFT) MALFUNCTION ALARM CODE WAS NOTED. 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, A S321 (MOTOR ERROR-PMC, LEFT) MALFUNCTION ALARM CODE NOTED IN THE DEVICE HISTORY. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252541 SYMBIQ FRENCH SINGLE 80 FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA