BEUDAMED
    FDA Adverse Event Other Summary report: N

    STOCKERT S5 SYSTEM

    MDR report key: 3844659 · Received May 15, 2014

    Report

    Report Number
    1718850-2014-00146
    Event Type
    Other
    Date Received
    May 15, 2014
    Date of Event
    April 16, 2014
    Report Date
    April 21, 2014
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DTQ
    PMA / PMN Number
    K071318
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT PROVIDED. SORIN GROUP (B)(4) MANUFACTURES THE S5 SYSTEM. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP RECEIVED A REPORT THAT THE S5 SYSTEM LOST POWER DURING A PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY. 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 THE STOCKERT S5 SYSTEM LOST POWER DURING A PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290956 STOCKERT S5 SYSTEM CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ SORIN GROUP DEUTSCHLAND 48-40-00 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NP