BEUDAMED
    FDA Adverse Event Other Summary report: N

    STOCKERT S5 SYSTEM

    MDR report key: 3875043 · Received June 9, 2014

    Report

    Report Number
    1718850-2014-00174
    Event Type
    Other
    Date Received
    June 9, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 13, 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

    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 PUMP OF THE S5 SYSTEM SWITCHED TO BATTERY MODE ON ITS OWN, EVEN THOUGH THE SYSTEM WAS PLUGGED INTO THE WALL OUTLET; THE PUMP DID NOT STOP. 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 PUMP OF THE S5 SYSTEM SWITCHED TO BATTERY MODE ON ITS OWN, EVEN THOUGH THE SYSTEM WAS PLUGGED INTO THE WALL OUTLET; THE PUMP DID NOT STOP. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335310 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