BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ DCHANNEL 3.01

    MDR report key: 4110402 · Received September 16, 2014

    Report

    Report Number
    9615050-2014-05249
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    January 1, 2014
    Report Date
    August 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER PERFORMED INITIAL TESTING AND INVESTIGATION AT THE USER FACILITY. DURING TESTING, THE DEVICE TOUCHSCREEN DID RESPOND WHEN PRESSED. DURING FURTHER TESTING AT THE SERVICE CTR, THE DEVICE TOUCHSCREEN RESPONDED; HOWEVER THE KEYS WERE OUT OF ALIGNMENT. DURING REVIEW OF THE DEVICE HISTORY TOUCHSCREEN ERRORS WERE NOTED. THE PROBABLE CAUSE OF THE NONRESPONSIVE TOUCHSCREEN WAS CONTAMINATION ON THE TOUCHSCREEN DUE TO FLUID INGRESS. THE DEVICE HAS 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 NOT WORKING. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPT FOR AN UNSPECIFIED REASON. NO INFO WAS PROVIDED; THEREFORE, SPECIFIC PT INFO, PUMP PROGRAMMING, OR EVENT DETAILS WERE NOT AVAILABLE. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS OR DELAYS IN CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. DURING TESTING AT THE USER FACILITY, THE DEVICE TOUCHSCREEN WAS NOT WORKING. NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573797 SYMBIQ DCHANNEL 3.01 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA