BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ DCHANNEL 3.01

    MDR report key: 3896024 · Received May 15, 2014

    Report

    Report Number
    9615050-2014-03446
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    January 1, 2014
    Report Date
    April 18, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K110901
    Removal / Correction Number
    Z-0072-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION FOUND THE DEVICE TOUCHSCREEN DID NOT PASS THE TOUCHSCREEN TEST AND DID NOT RESPOND WHEN PRESSED. THE PROBABLE CAUSE WAS DUE TO CONTAMINATION ON THE DEVICE TOUCHSCREEN DUE TO FLUID INGRESS. THE 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 WAS NOT WORKING. THE DEVICE WAS RETUREND 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 OR DELAYS IN CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. DURING TESTING AT THE USER FACILITY THE DEVICE TOUCHSCREEN DID NOT RESPOND WHEN PRESSED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290830 SYMBIQ DCHANNEL 3.01 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK