BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ DCHANNEL 3.01

    MDR report key: 4213607 · Received October 24, 2014

    Report

    Report Number
    9615050-2014-05725
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Date of Event
    October 6, 2014
    Report Date
    October 6, 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
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION FOUND THE TOUCHSCREEN WAS RESPONSIVE, BUT THE KEY ALIGNMENT WAS OFF-CENTERED. THE TOUCHSCREEN WAS SUCCESSFULLY RECALIBRATED AND THE KEY ALIGNMENT WAS CENTERED. THE PROBABLE CAUSE WAS DUE TO CONTAMINATION ON THE BOTTOM OF THE TOUCHSCREEN DUE TO FLUID INGRESS. AS INDICATED, 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 THAT DURING PREVENTIVE MAINTENANCE TESTING AT THE USER FACILITY, THE DEVICE TOUCHSCREEN DOES NOT CALIBRATE. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS OR DELAYS IN CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678590 SYMBIQ DCHANNEL 3.01 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA