BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO CONSOLE

    MDR report key: 1972504 · Received January 12, 2011

    Report

    Report Number
    2184009-2011-00005
    Event Type
    Injury
    Date Received
    January 12, 2011
    Date of Event
    December 10, 2010
    Report Date
    December 14, 2010
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    DWA
    PMA / PMN Number
    K924205
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION = DEVICE HISTORY REVIEWED. RESULT = DEVICE HISTORY REVIEW FOUND THE PRODUCT MET SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. CONCLUSION: CAUSE OF EVENT CANNOT BE DETERMINED. ANALYSIS: THE UNIT WAS ANALYZED IN THE FIELD BY TECHNICAL SERVICES TECHNICIANS. THE UNIT WAS RAN FOR OVER AN HOUR AND IT FUNCTIONED NORMALLY WITH NO ERRORS FOUND. REASON FOR PUMP FAILING TO PRODUCE FLOW IS UNK. CONCLUSION: THE REASON FOR THE PUMP FAILING TO PRODUCE FLOW COULD NOT BE DETERMINED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIO CONSOLE DWA MEDTRONIC PERFUSION SYSTEMS 550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1