BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMAX PLUS W/HARDSHELL

    MDR report key: 1982487 · Received January 10, 2011

    Report

    Report Number
    2184009-2011-00004
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    December 9, 2010
    Report Date
    December 12, 2010
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    DTZ
    PMA / PMN Number
    K933586
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, METHOD: OTHER - DEVICE HISTORY REVIEW IS PENDING. NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS. RESULTS: OTHER - DEVICE HISTORY REVIEW IS PENDING, AS IS PRODUCT RETURN. CONCLUSION: OTHER - CAUSE OF EVENT CANNOT BE DETERMINED. ANALYSIS: THE PRODUCT HAS NOT BEEN RETURNED FOR ANALYSIS AT THIS TIME. CONCLUSION: DUE TO THE LIMITED INFORMATION AVAILABLE AT THIS TIME, A CAUSE FOR THIS EVENT COULD NOT BE DETERMINED. SHOULD ADDITIONAL INFORMATION BE PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT DURING RE-WARMING, THIS OXYGENATOR WAS FOUND TO HAVE HIGH ARTERIAL LINE PRESSURE. THE DEVICE WAS CHANGED OUT WITH NO PATIENT EFFECT. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINIMAX PLUS W/HARDSHELL DTZ MEDTRONIC PERFUSION SYSTEMS 3301 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention