BEUDAMED
    FDA Adverse Event Other Summary report: N

    S5 DOUBLE HEAD PUMP

    MDR report key: 2755757 · Received September 14, 2012

    Report

    Report Number
    1718850-2012-00980
    Event Type
    Other
    Date Received
    September 14, 2012
    Date of Event
    August 15, 2012
    Report Date
    August 15, 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

    SORIN GROUP (B)(4) MANUFACTURES THE S5 TOUCH SCREEN, WHICH IS A COMPONENT OF THE S5 DOUBLE HEAD PUMP. THE 510(K) NUMBER OF THE S5 DOUBLE HEAD PUMP IS K060053. THE INCIDENT OCCURRED IN (B)(4). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP RECEIVED A REPORT THAT THE TOUCH SCREEN OF THE S5 DOUBLE HEAD PUMP WAS INTERMITTENTLY FUNCTIONING AND WOULD RESPOND INCORRECTLY TO TOUCH. THERE WAS NO PT INJURY. THE INVESTIGATION IS ON-GOING. A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT THE TOUCH SCREEN OF THE S5 DOUBLE HEAD PUMP WAS INTERMITTENTLY FUNCTIONING AND WOULD RESPOND INCORRECTLY TO TOUCH. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S5 DOUBLE HEAD PUMP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ SORIN GROUP DEUTSCHLAND 10-85-00 NA

    Patients

    Seq Age Sex Outcome Treatment
    1