BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ DUAL CHANNEL

    MDR report key: 4102379 · Received August 27, 2014

    Report

    Report Number
    9615050-2014-04983
    Event Type
    Malfunction
    Date Received
    August 27, 2014
    Date of Event
    January 1, 2014
    Report Date
    August 20, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K110901
    Removal / Correction Number
    Z-0070-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER PERFORMED TESTING AND INVESTIGATION AT THE USER FACILITY. DURING TESTING THE TOUCHSCREEN WAS FOUND TO BE OUT OF CALIBRATION. THE DEVICE HAS BEEN IDENTIFIED AS PART OF A PRODUCT RECALL. 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 TOUCHSCREEN NEEDS CALIBRATION, CANNOT ACCESS THE "MODE" BUT POSSIBLE TO ACCESS THE "SELECT CCA" BY PRESSING BELOW THE BUTTON. THERE WERE NO REPORTS OF ANY PT INVOLVEMENT, ADVERSE PT EVENTS, OR DELAYS IN CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. DURING TESTING AT THE USER FACILITY, IT WAS FOUND THE DEVICE TOUCHSCREEN WAS OUT OF CALIBRATION. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522509 SYMBIQ DUAL CHANNEL 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA