BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ SINGLE CHANNE

    MDR report key: 3874244 · Received April 18, 2014

    Report

    Report Number
    9615050-2014-02809
    Event Type
    Malfunction
    Date Received
    April 18, 2014
    Date of Event
    March 20, 2014
    Report Date
    March 20, 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
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION FOUND THE DEVICE MECHANISM ALARMED WITH A S321 MALFUNCTION ALARM CODE AND THE MOTOR WAS LOOSE. THE PROBABLE CAUSE OF THE S321 WAS A LOOSE MOTOR DUE TO THE UNDER APPLICATION OF THE ADHESIVE SEAL OR THE ADHESIVE SEAL BEING APPLIED OVER GREASE. 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 PREVENTATIVE MAINTENANCE TESTING THE DEVICE ALARMED WITH A S321 (MOTOR ERROR-PMC, LEFT) MALFUNCTION ALARM CODE. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS AND NO REPORTED DELAYS IN CRITICAL THERAPY WHILE THE DEVICE WAS IN CLINICAL USE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238534 SYMBIQ SINGLE CHANNE 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA