BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ DUAL CHANNEL

    MDR report key: 3820484 · Received April 9, 2014

    Report

    Report Number
    9615050-2014-02556
    Event Type
    Malfunction
    Date Received
    April 9, 2014
    Date of Event
    March 10, 2014
    Report Date
    March 10, 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
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION FOUND THE DEVICE TOUCHSCREEN RESPONDED INTERMITTENTLY WHEN PRESSED. DURING A REVIEW OF THE DEVICE HISTORY AT THE SERVICE CENTER BUTTON ID: INVALID ERROR CODES WERE NOTED. THE PROBABLE CAUSE OF THE INTERMITTENT TOUCHSCREEN WAS CORROSION ON THE TOUCHSCREEN AND CONTAMINATION ON THE BOTTOM TOUCHSCREEN CONNECTORS DUE TO FLUID INGRESS. THIS 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 INTERMITTENTLY DOES NOT RESPOND WHEN PRESSED. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS OR DELAYS IN CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213299 SYMBIQ DUAL CHANNEL 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA