BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ SINGLE CHANNEL

    MDR report key: 3102452 · Received May 2, 2013

    Report

    Report Number
    9615050-2013-01017
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    March 25, 2013
    Report Date
    April 4, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K041550
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. 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 A WHITESCREEN ERROR. DURING TESTING AT THE USER FACILITY AFTER THE DEVICE WAS POWER ON, THE DEVICE ALARMED WITH A WHITESCREEN ERROR. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS OR DELAYS IN 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
    192758 SYMBIQ SINGLE CHANNEL 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA