BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ FRENCH SINGLE

    MDR report key: 4212938 · Received August 4, 2014

    Report

    Report Number
    9615050-2014-04674
    Event Type
    Malfunction
    Date Received
    August 4, 2014
    Date of Event
    October 13, 2013
    Report Date
    November 12, 2013
    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 WAS 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 DEVICE MECHANISM WAS RETURNED TO THE SERVICE CTR FOR A REPORT OF S320 (LED ERROR -PMC, LEFT) MALFUNCTION ALARM CODE. THIS DID NOT INDICATE A REPORTABLE MALFUNCTION. HOWEVER DURING VERIFICATION TESTING AT THE SERVICE CTR, THE DEVICE MECHANISM ALARMED WITH A S321 (MOTOR ERROR-PMC, LEFT) MALFUNCTION ALARM CODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455521 SYMBIQ FRENCH SINGLE 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA