BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIO-CONSOLE

    MDR report key: 95374 · Received May 28, 1997

    Report

    Report Number
    2124837-1997-00011
    Event Type
    Malfunction
    Date Received
    May 28, 1997
    Date of Event
    April 28, 1997
    Report Date
    May 27, 1997
    Manufacturer
    MEDTRONIC BIO-MEDICUS, INC.
    Product Code
    DWA
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HOSP REPORTED THAT DURING A CASE, THE ALARMS ON THE BIO-CONSOLE BEGAN TO SOUND AND THE CONSOLE MOTOR WOULD NOT OPERATE. A HANDCRANK WAS USED WHILE THE BIO-CONSOLE WAS REPLACED WITH A SECOND UNIT. THE CASE WAS CONTINUED WITH NO EFFECT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIO-CONSOLE CARDIOPULMONARY BYPASS PUMP SPEED CONTROL DWA MEDTRONIC BIO-MEDICUS, INC. 540 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other