BEUDAMED
    FDA Adverse Event Other Summary report: N

    LCD WITH TOUCHSCREEN

    MDR report key: 2648509 · Received June 27, 2012

    Report

    Report Number
    1718850-2012-00717
    Event Type
    Other
    Date Received
    June 27, 2012
    Date of Event
    June 21, 2011
    Report Date
    June 14, 2012
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DTQ
    PMA / PMN Number
    K071318
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURERS THE LCD WITH TOUCHSCREEN. THE INCIDENT OCCURRED IN (B)(6). THIS MDR REPORT IS BEING SUBMITTED ON BEHALF OF THE DEVICE MANUFACTURER - 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 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 DEVICE WAS RETURNED TO SORIN (B)(4) FOR EVALUATION. AT SORIN GROUP (B)(4), THE DEVICE WAS SUBJECTED TO FUNCTIONAL TESTING UNDER NORMAL OPERATING CONDITIONS AND ELECTRICAL TESTING. NO ERRORS OR DEVIATIONS WERE ENCOUNTERED AT ANY POINT DURING FUNCTIONAL OR ELECTRICAL TESTING. THE REPORTED ISSUE COULD NOT BE REPRODUCED. WITHOUT THE ABILITY TO REPRODUCE THE ISSUE, THE ROOT CAUSE COULD NOT BE CONFIRMED. NO FURTHER ACTION IS DEEMED NECESSARY.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE TOUCHSCREEN WAS UNRESPONSIVE. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LCD WITH TOUCHSCREEN CONSOLE HEART LUNG MACHINE CARDIOPULMONARY BYPASS DTQ SORIN GROUP DEUTSCHLAND 97-103-616 NA

    Patients

    Seq Age Sex Outcome Treatment
    1