BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S5 CONTROL DISPLAY MODULE

    MDR report key: 2597839 · Received May 16, 2012

    Report

    Report Number
    1718850-2012-00321
    Event Type
    Malfunction
    Date Received
    May 16, 2012
    Date of Event
    July 22, 2010
    Report Date
    April 30, 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
    MN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE S5 CONTROL DISPLAY MODULE. THE DISPLAY MODULE IS A COMPONENT OF THE S5 SYSTEM. THE 510(K) NUMBER FOR THE S5 ROLLER PUMP IS K060053. THE INCIDENT OCCURRED IN (B)(6). THIS MDR REPORT IS BEING SUBMITTED ON BEHALF OF THE DEVICE MFR - SORIN GROUP (B)(4). TO RESOLVE AN FDA INSPECTIONAL OBSERVATION, THE SORIN GROUP (B)(4) MDR PROCEDURE WAS REVISED. AS COMMITTED TO FDA'S OFFICE OF COMPLIANCE, A RETROSPECTIVE REVIEW OF CUSTOMER REVIEW OF CUSTOMER COMPLAINTS IS BEING PERFORMED AND MDRS WILL BE SUBMITTED IN ACCORDANCE WITH THE REVISED PROCEDURE. THIS MDR IS BEING SUBMITTED BEYOND THE 30 DAY REPORTING REQUIREMENT AS IT WAS IDENTIFIED DURING THE RETROSPECTIVE REVIEW. THE UNRESPONSIVE TOUCH SCREEN OBSERVED BY THE USER WAS DUE TO A LOSS OF ELECTRICAL CONTACT AT THE CABLE CONNECTION. FIELD ACTIONS WERE IMPLEMENTED TO ADDRESS THIS SPECIFIC ISSUE (REF FDA RECALL NUMBER Z-0956-2011 THROUGH Z-0965-2011 AND Z-1149-2012 THROUGH Z-1158-2012). TO DATE THERE HAVE BEEN NO REPORTED INJURIES AS A RESULT OF THIS ISSUE. NO FURTHER ACTION IS DEEMED NECESSARY.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT THE TOUCH SCREEN WOULD NOT RESPOND. 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