BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ SCHANNEL 3.01

    MDR report key: 3862946 · Received February 20, 2014

    Report

    Report Number
    9615050-2014-01358
    Event Type
    Malfunction
    Date Received
    February 20, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 22, 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
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER PERFORMED TESTING AND INVESTIGATION AT THE USER FACILITY. DURING TESTING, THE DEVICE TOUCHSCREEN WAS FOUND TO BE BROKEN AND WOULD NOT CALIBRATE. THE DEVICE HAS BEEN IDENTIFIED AS PART OF A PRODUCT RECALL. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE RPTR UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE DEVICE TOUCHSCREEN WAS OUT OF CALIBRATION. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPT WITH AN UNSIGNED NOTE THAT INDICATED THE DEVICE WAS OUT OF CALIBRATION. NO TRACKING INFO WAS PROVIDED; THEREFORE, SPECIFIC PT INFO, DEVICE PROGRAMMING, OR EVENT DETAILS WERE NOT AVAILABLE. THERE WERE NO REPORTED ADVERSE PT EVENTS OR DELAYS IN CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. DURING TESTING AT THE USER FACILITY, THE DEVICE TOUCHSCREEN COULD NOT BE CALIBRATED. NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106784 SYMBIQ SCHANNEL 3.01 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK