BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETROGRADE CARDIOPLEGIA CANNULA

    MDR report key: 83744 · Received April 8, 1997

    Report

    Report Number
    1713910-1997-00007
    Event Type
    Malfunction
    Date Received
    April 8, 1997
    Report Date
    April 7, 1997
    Manufacturer
    RESEARCH MEDICAL, INC.
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A SECOND EVALUATION OF THIS EVENT IT WAS DECIDED THE EVENT SHOULD HAVE BEEN REPORTED ON THE REPORTED PRODUCT CODE THE STOPCOCK CAME OFF THE INFLATION LINE DURING USE. THERE WAS NO ADVERSE IMPACT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RETROGRADE CARDIOPLEGIA CANNULA CARDIOLEGIA CANNULA DWF RESEARCH MEDICAL, INC. N/A 87633

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other