BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ 3.13 SINGLE C

    MDR report key: 4122008 · Received September 19, 2014

    Report

    Report Number
    9615050-2014-05322
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    January 1, 2014
    Report Date
    September 3, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K110901
    Removal / Correction Number
    Z-0069-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER PERFORMED TESTING AND INVESTIGATION AT THE USER FACILITY. DURING TESTING THE DEVICE TOUCHSCREEN WAS FOUND TO BE OUT OF CALIBRATION. THE TOUCH POINTS ON THE TOUCHSCREEN WERE OFF CENTER. THE PROBABLE CAUSE WAS A BROKEN TOUCHSCREEN. 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 THE DEVICE TOUCHSCREEN WOULD NOT CALIBRATE. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPARTMENT FROM INTENSIVE CARE. IT WAS INDICATED THERE WAS NO PATIENT INVOLVEMENT. 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 CUT OF CALIBRATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583631 SYMBIQ 3.13 SINGLE C 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA