BEUDAMED
    FDA Adverse Event Other Summary report: N

    S5 CONTROL DISPLAY MODULE

    MDR report key: 2705303 · Received August 8, 2012

    Report

    Report Number
    1718850-2012-00959
    Event Type
    Other
    Date Received
    August 8, 2012
    Date of Event
    July 12, 2012
    Report Date
    August 9, 2012
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DTQ
    PMA / PMN Number
    K060053
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PT INFO WAS PROVIDED. SORIN GROUP (B)(4) MANUFACTURES THE S5 CONTROL DISPLAY MODULE WHICH IS A COMPONENT OF THE STOCKERT S5 SYSTEM. THE 510(K) NUMBER OF THE STOCKERT S5 SYSTEM IS K060053. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). THE INVESTIGATION IS ON-GOING. A FOLLOW UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT DURING A PROCEDURE, ONE OF THE TOUCH SCREENS OF THE S5 SYSTEM WAS UNRESPONSIVE. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S5 CONTROL DISPLAY MODULE CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ SORIN GROUP DEUTSCHLAND 28-95-10 NA

    Patients

    Seq Age Sex Outcome Treatment
    1