BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ SCHANNEL 3.01

    MDR report key: 4173521 · Received October 10, 2014

    Report

    Report Number
    9615050-2014-05583
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    January 1, 2014
    Report Date
    September 23, 2014
    Manufacturer
    HOSPIRA HOLDINGS DE 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION FOUND THE TOUCHSCREEN DID NOT RESPOND WHEN PRESSED ALONG THE RIGHT SIDE AND CENTER OF THE LCD TOUCHSCREEN DISPLAY. FURTHER TESTING FOUND EVIDENCE OF CORROSION DUE TO FLUID INGRESS ON THE LOWER LEFT, AND RIGHT BOTTOM CORNER ON THE TOUCHSCREEN AND FRONT BEZEL, WHICH MAY HAVE CONTRIBUTED TO THE CUSTOMER'S REPORT AND ALTERED THE CHARACTERISTICS OF THE 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 FOR AN UNSPECIFIED REASON. NO INFORMATION WAS PROVIDED; THEREFORE, SPECIFIC PATIENT INFORMATION, PUMP PROGRAMMING, OR EVENT DETAILS WERE NOT AVAILABLE. 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 WOULD NOT CALIBRATE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643156 SYMBIQ SCHANNEL 3.01 80 FRN HOSPIRA HOLDINGS DE COSTA RICA LTD. NA

    Patients

    Seq Age Sex Outcome Treatment
    1