BEUDAMED
    FDA Adverse Event Other Summary report: N

    S5 CONTROL PANEL MRP 150/85

    MDR report key: 3733339 · Received March 26, 2014

    Report

    Report Number
    1718850-2014-00077
    Event Type
    Other
    Date Received
    March 26, 2014
    Date of Event
    February 18, 2014
    Report Date
    February 27, 2014
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DTQ
    PMA / PMN Number
    K062396
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE S5 CONTROL PANEL. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP RECEIVED A REPORT THAT DURING TESTING OF THE SYSTEM THE SGU FIELD SERVICE REP FOUND THAT THE S5 CONTROL PANEL WAS DISPLAYING INCONSISTENT FLOW CONTROL. THE INVESTIGATION IS ONGOING. 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 TESTING OF THE SYSTEM THE SGU FIELD SERVICE REP FOUND THAT THE S5 CONTROL PANEL WAS DISPLAYING INCONSISTENT FLOW CONTROL. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176294 S5 CONTROL PANEL MRP 150/85 CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ SORIN GROUP DEUTSCHLAND 28-95-80 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA