BEUDAMED
    FDA Adverse Event Other Summary report: N

    S5 SYSTEM

    MDR report key: 1780856 · Received July 27, 2010

    Report

    Report Number
    1718850-2010-00128
    Event Type
    Other
    Date Received
    July 27, 2010
    Date of Event
    June 28, 2010
    Report Date
    June 29, 2010
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DTQ
    PMA / PMN Number
    K071318
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION HAS BEEN REQUESTED BUT NOT PROVIDED. SORIN GROUP (B)(4) MANUFACTURES THE DISPLAY MODULE. THE 510(K) NUMBER IS K071318. THE INCIDENT OCCURRED AT (B)(6) CLINICAL CENTER. THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). THE PERFUSIONIST REPORTED THAT THE TOUCH SCREEN DID NOT FUNCTION DURING THE CASE. SORIN GROUP (B)(4) HAS REQUESTED ADDITIONAL INFORMATION FROM THE FACILITY REGARDING THIS INCIDENT. TO DATE, THE PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION. THE INVESTIGATION IS ON-GOING. A FOLLOW-UP REPORT WILL BE FORWARDED WHEN THE INVESTIGATION IS COMPLETE. THE FACILITY FILED A VIGILANCE REPORT WITH THE COUNTRY'S COMPETENT AUTHORITY. THIS MEDWATCH REPORT IS FILED AS A RESULT OF THIS ACTION.

    Description of Event or Problem · 1

    THE PERFUSIONIST REPORTED THAT THE TOUCH SCREEN DID NOT FUNCTION DURING THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S5 SYSTEM HEART-LUNG MACHINE, CONSOLE DTQ SORIN GROUP DEUTSCHLAND NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1