BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ SCHANNEL 3.01

    MDR report key: 3853625 · Received April 3, 2014

    Report

    Report Number
    9615050-2014-02516
    Event Type
    Malfunction
    Date Received
    April 3, 2014
    Date of Event
    March 1, 2014
    Report Date
    March 4, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION FOUND THE RIGHT SIDE OF THE TOUCHSCREEN DID NOT RESPOND. DURING TESTING A REVIEW OF THE DEVICE HISTORY INDICATED TOUCHSCREEN FAIL ERRORS OCCURRED. THIS WAS DUE TO THE TOUCHSCREEN OUT OF CALIBRATION AND CORROSION ON THE TOUCHSCREEN. THE PROBABLE CAUSE OF THE CUSTOMERS REPORTED TOUCHSCREEN NOT RESPONDING WAS THE TOUCHSCREEN OUT OF CALIBRATION AND CORROSION ON THE TOUCHSCREEN DUE TO FLUID INGRESS. 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 THE DEVICE TOUCHSCREEN WAS NOT WORKING. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPARTMENT WITH A REPORT OF TOUCHSCREEN NOT WORKING. NO INFORMATION WAS PROVIDED; THEREFORE, SPECIFIC PATIENT INFORMATION, PUMP PROGRAMMING, OR EVENT DETAILS WERE NOT AVAILABLE. THERE WERE NO REPORTED ADVERSE PATIENT EVENTS, NO NEED FOR MEDICAL INTERVENTION AND NO DELAYS IN CRITICAL THERAPY WHILE THE DEVICE WSA IN CLINICAL USE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203287 SYMBIQ SCHANNEL 3.01 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK