BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIO-CONSOLE

    MDR report key: 228835 · Received June 16, 1999

    Report

    Report Number
    2124837-1999-00006
    Event Type
    Malfunction
    Date Received
    June 16, 1999
    Date of Event
    May 18, 1999
    Manufacturer
    MEDTRONIC BIO-MEDICUS, INC.
    Product Code
    DWA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HOSPITAL REPORTED THAT NEAR THE END OF BYPASS, THE PERFUSIONIST TURNED THE RPM'S OFF FOR A SHORT PERIOD OF TIME AND WHEN HE TURNED THEM BACK ON, THE MOTOR WOULD NOT ROTATE. A BACKUP HANDCRANK DEVICE WAS USED TO CONTINUE CASE WITH NO EFFECT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIO-CONSOLE CARDIOPULMONARY BYPASS PUMP SPEED CONTROLLER DWA MEDTRONIC BIO-MEDICUS, INC. 550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other