BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ SINGLE CHANNEL

    MDR report key: 3912715 · Received May 14, 2014

    Report

    Report Number
    9615050-2014-03401
    Event Type
    Malfunction
    Date Received
    May 14, 2014
    Date of Event
    January 1, 2014
    Report Date
    April 15, 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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER PERFORMED TESTING AND INVESTIGATION AT THE USER FACILITY. DURING TESTING, THE DEVICE DID NOT PASS TOUCHSCREEN TEST. THE DEVICE HAS BEEN IDENTIFIED AS PART OF A PRODUCT RECALL. THIS REPORT REPRESENTS ALL INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPITAL PERSONNEL.

    Description of Event or Problem · 1

    DURING TESTING AT THE USER FACILITY, IT WAS NOTED THE TOUCHSCREEN DID NOT PASS THE TOUCHSCREEN TEST. PRIOR TO TESTING, THE CUSTOMER CONTACT REPORTED CORROSION ON THE TOUCHSCREEN DUE TO SPILLAGE. 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
    287957 SYMBIQ SINGLE CHANNEL 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA