BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ DCHANNEL 3.01

    MDR report key: 4102388 · Received August 27, 2014

    Report

    Report Number
    9615050-2014-04980
    Event Type
    Malfunction
    Date Received
    August 27, 2014
    Date of Event
    January 1, 2014
    Report Date
    August 7, 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

    TESTING AND INVESTIGATION AT THE SERVICE CTR FOUND THE DEVICE TOUCHSCREEN DID NOT PASS THE TOUCHSCREEN TEST AND COULD NOT BE CALIBRATED. FURTHER TESTING FOUND THE TOUCHSCREEN RESPONSE WAS INTERMITTENT AND THE KEYS WOULD ARBITRARILY GET STUCK AND NOT RESPOND WHEN PRESSED. THIS WAS DUE TO CONTAMINATION ON THE BOTTOM EDGE OF THE TOUCHSCREEN CAUSED BY 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 WOULD NOT WORK. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPARTMENT FOR AN UNSPECIFIED REASON. NO SPECIFIC PT INFO, PUMP PROGRAMMING, OR EVENT DETAILS WERE PROVIDED. 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 DID NOT PASS THE TOUCHSCREEN TEST. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518926 SYMBIQ DCHANNEL 3.01 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK