BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ DUAL CHANNEL

    MDR report key: 3962846 · Received June 13, 2014

    Report

    Report Number
    9615050-2014-04011
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    January 1, 2014
    Report Date
    May 21, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K110901
    Removal / Correction Number
    Z0070-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER PERFORMED TESTING AND INVESTIGATION AT THE USER FACILITY. DURING TESTING, THE TOUCHSCREEN WAS FOUND TO BE OUT OF CALIBRATION. 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 PREVENTIVE MAINTENANCE TESTING AT THE USER FACILITY THE DEVICE TOUCHSCREEN WOULD NOT CALIBRATE. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE DEVICE WAS AVAILABLE FOR CLINICAL USE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351313 SYMBIQ DUAL CHANNEL 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA