BEUDAMED
    FDA Adverse Event Death Summary report: N

    ECMO SILICONE OXYGENATOR

    MDR report key: 1672641 · Received April 28, 2010

    Report

    Report Number
    2184009-2010-00005
    Event Type
    Death
    Date Received
    April 28, 2010
    Date of Event
    March 25, 2010
    Report Date
    March 29, 2010
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    DTZ
    PMA / PMN Number
    K883053
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4): EVAL: RESULTS: DEVICE HISTORY WAS NOT PERFORMED YET. CAUSE OF THIS EVENT COULD NOT BE DETERMINED. ANALYSIS: THE DEVICE HAS BEEN RETURNED FOR ANALYSIS. COMPLETION OF ANALYSIS AND FULL INVESTIGATION IS PENDING. ONCE COMPLETE, THE EVENT WILL BE UPDATED AND A SUPPLEMENTAL REPORT FILED. CONCLUSION: THE CAUSE OF THIS EVENT CANNOT BE DETERMINED AT THIS TIME.

    Description of Event or Problem · 1

    .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECMO SILICONE OXYGENATOR DTZ MEDTRONIC PERFUSION SYSTEMS 1500 ECMO NA

    Patients

    Seq Age Sex Outcome Treatment
    1