BEUDAMED
    FDA Adverse Event Summary report: N

    SYMBIQ 3.13 DUAL CHA

    MDR report key: 4241236 · Received October 30, 2014

    Report

    Report Number
    9615050-2014-05830
    Date Received
    October 30, 2014
    Date of Event
    January 1, 2014
    Report Date
    October 14, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD
    Product Code
    FRN
    PMA / PMN Number
    K110901
    Removal / Correction Number
    Z-0070-2013
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER PERFORMED TESTING AND INVESTIGATION AT THE USER FACILITY. DURING TESTING THE DEVICE FAILED TOUCHSCREEN TESTING AND THE KEYS WERE OUT OF ALIGNMENT. THE PROBABLE CAUSE IS DUE TO THE DEVICE TOUCHSCREEN WAS OUT OF CALIBRATION. 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 DURING PREVENTATIVE MAINTENANCE TESTING AT THE USER FACILITY, THE DEVICE TOUCHSCREEN WAS NOT WORKING AND WAS OUT OF CALIBRATION. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS OR DELAYS IN CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. DURING FURTHER TESTING AT THE USER FACILITY, THE DEVICE FAILED TOUCHSCREEN TESTING AND THE KEYS WERE OUT OF ALIGNMENT. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697045 SYMBIQ 3.13 DUAL CHA 80FRN FRN HOSPIRA COSTA RICA LTD NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA