BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ SINGLE CHANNE

    MDR report key: 3837661 · Received April 11, 2014

    Report

    Report Number
    9615050-2014-02635
    Event Type
    Malfunction
    Date Received
    April 11, 2014
    Date of Event
    February 24, 2014
    Report Date
    March 13, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K110901
    Removal / Correction Number
    A-0069-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION FOUND THAT THE DEVICE PASSED TESTING; HOWEVER, A REVIEW OF THE DEVICE HISTORY INDICATED TOUCHSCREEN FAIL ERRORS. ADDITIONAL TESTING FOUND CONTAMINATION ON THE BOTTOM OF THE TOUCHSCREEN. THE PROBABLE CAUSE OF THE CUSTOMER REPORTED UNABLE TO CALIBRATE TOUCHSCREEN WAS DUE TO FLUID INGRESS. THIS 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 THAT DURING TESTING THE DEVICE TOUCHSCREEN WOULD NOT CALIBRATE. THERE WERE NO REPORTED ADVERSE PATIENT EVENTS, NO NEED FOR MEDICAL INTERVENTION AND NO DELAYS IN CRITICAL THERAPY WHILE THE DEVICE WAS IN CLINICAL USE. DURING TESTIN GAT THE USER FACILITY, THE DEVICE TOUCHSCREEN WOULD NOT CALIBRATE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221353 SYMBIQ SINGLE CHANNE 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA