BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ DUAL CHANNEL

    MDR report key: 3822778 · Received February 7, 2014

    Report

    Report Number
    9615050-2014-00987
    Event Type
    Malfunction
    Date Received
    February 7, 2014
    Date of Event
    November 1, 2013
    Report Date
    January 9, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K110901
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION FOUND AT POWER UP, THE DEVICE DISPLAYED A WHITESCREEN ERROR WITHOUT AN AUDIBLE ALARM TONE. THE PROBABLE CAUSE WAS DUE TO A LOOSE RIBBON CABLE CONNECTED TO THE FRONT DISPLAY ON THE UIC (USER INTERFACE CONTROLLER). THE LOOSE CABLE DOES NOT TRIGGER AN ALARM CONDITION. THE CAUSE OF THE LOOSE CABLE COULD NOT BE DETERMINED. 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 THAT DURING TESTING AT THE USER FACILITY, THE DEVICE ALARMED WITH A WHITESCREEN ERROR. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80855 SYMBIQ DUAL CHANNEL 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA