BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ SCHANNEL 3.01

    MDR report key: 3843509 · Received March 14, 2014

    Report

    Report Number
    9615050-2014-01968
    Event Type
    Malfunction
    Date Received
    March 14, 2014
    Date of Event
    January 1, 2014
    Report Date
    February 13, 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
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION FOUND THE TOUCHSCREEN RESPONDED BUT THE KEY ALIGNMENT WAS OFF. DURING A REVIEW OF THE DEVICE HISTORY BUTTON ID INVALID ALARM CODES WERE NOTED. THIS WAS DUE TO THE TOUCHSCREEN BEING OUT OF CALIBRATION AND CONTAMINATION AT THE BOTTOM OF THE TOUCHSCREEN CONNECTORS. THE PROBABLE CAUSE IS FLUID INGRESS. THIS DEVICE DHAS BEEN IDENTIFIED AS PART OF A PRODUCT RECALL. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE DEVICE TOUCHSCREEN DOES NOT RESPOND. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPARTMENT FOR AN UNSPECIFIED REASON. NO ADDITIONAL INFO, PUMP PROGRAMMING, OR EVENT DETAILS WERE AVAILABLE. THERE WERE UNK REPORTS OF ANY ADVERSE PT EVENTS AND UNK REPORTS DELAY IN CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154444 SYMBIQ SCHANNEL 3.01 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK