BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ SCHANNEL 3.01

    MDR report key: 3902112 · Received May 2, 2014

    Report

    Report Number
    9615050-2014-03166
    Event Type
    Malfunction
    Date Received
    May 2, 2014
    Date of Event
    March 26, 2014
    Report Date
    April 4, 2014
    Manufacturer
    HOSPIRA HOLDINGS DE 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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION FOUND THE TOUCHSCREEN DID NOT RESPOND. THE PROBABLE CAUSE WAS DUE TO CONTAMINATION ON THE BOTTOM OF THE TOUCHSCREEN DUE TO 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 WAS NOT WORKING. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. DURING TESTING AT THE USER FACILITY, THE DEVICE TOUCHSCREEN WOULD NOT CALIBRATE. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265626 SYMBIQ SCHANNEL 3.01 80FRN FRN HOSPIRA HOLDINGS DE COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA