BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCP00703159#RFC 20-970 ROTAFLOW CONSOLE

    MDR report key: 4821478 · Received June 4, 2015

    Report

    Report Number
    3008355164-2015-00111
    Event Type
    Injury
    Date Received
    June 4, 2015
    Date of Event
    May 4, 2015
    Report Date
    May 7, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT TURNED OFF ON ITS OWN DURING PT TREATMENT. WHEN TURNED BACK ON, THE VALUES FOR LITERS/MINUTE DID NOT SHOW UP BUT THE RPM WAS STILL DISPLAYED. THIS OCCURRED TOWARDS THE END OF THE PROCEDURE. (B)(4).

    Description of Event or Problem · 1

    (B)(4). THE DEVICE WAS EVALUATED BY A MAQUET SERVICE TECHNICIAN WHO CONFIRMED THE REPORTED PROBLEM AND REPLACED THE CONTROL BOARD. THE DATA IS BEING HANDLED THROUGH A DESIGNATED MAQUET CARDIOPULMONARY TRENDING AND APPLICABLE INVESTIGATION PROCESS. (B)(4). REFERENCE MFR # 8010762-2015-00682.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361790 MCP00703159#RFC 20-970 ROTAFLOW CONSOLE DTQ MAQUET CARDIOPULMONARY AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention