BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ DUALCHAN INF

    MDR report key: 3964177 · Received May 28, 2014

    Report

    Report Number
    9615050-2014-03676
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    January 1, 2014
    Report Date
    April 28, 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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION WAS DONE AT THE USER FACILITY BY THE FIELD SERVICE ENGINEER. DURING TESTING IT WS FOUND THE DEVICE TOUCHSCREEN WAS FOUND TO BE OUT OF CALIBRATION. THIS 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 THAT DURING TESTING AT THE USER FACILITY THE DEVICE COULD NOT ACCESS THE BIOMED MODE WHEN THE TOUCHSCREEN WAS PRESSED. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. DURING TESTING AT THE USER FACILITY THE DEVICE TOUCHSCREEN WAS FOUND TO BE OUT OF CALIBRATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314683 SYMBIQ DUALCHAN INF 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA