BEUDAMED
    FDA Adverse Event Other Summary report: N

    STOCKERT S5 SYSTEM

    MDR report key: 3031897 · Received March 25, 2013

    Report

    Report Number
    1718850-2013-00040
    Event Type
    Other
    Date Received
    March 25, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 26, 2013
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DTQ
    PMA / PMN Number
    K060053
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A SERVICE REQUEST FROM A CUSTOMER FOR THEIR STOCKERT S5 SYSTEM. THE REPORT INDICATED THERE WAS A PT INCIDENT. REQUESTS WERE MADE BUT THE HOSPITAL HAS NOT PROVIDED ANY INFO REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121651 STOCKERT S5 SYSTEM CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ SORIN GROUP DEUTSCHLAND 48-40-00 NA

    Patients

    Seq Age Sex Outcome Treatment
    1