BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ DCHANNEL 3.01

    MDR report key: 3843467 · Received March 14, 2014

    Report

    Report Number
    9615050-2014-01953
    Event Type
    Malfunction
    Date Received
    March 14, 2014
    Date of Event
    January 1, 2014
    Report Date
    February 12, 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
    WA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION AT THE USER FACILITY BY A FIELD SERVICE ENGINEER FOUND THAT THE DEVICE DID NOT PASS THE TOUCHSCREEN TEST. THE PROBABLE CAUSE WAS A BROKEN FRONT BEZEL ASSEMBLY. 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 DOES NOT RESPOND AND WILL NOT TURN OFF. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPARTMENT FOR AN UNK REASON. NO SPECIFIC DETAILS WERE PROVIDED. THERE WAS UNK ADVERSE EVENT, OR DELAY IN CRITICAL THERAPY. NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153721 SYMBIQ DCHANNEL 3.01 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK