BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIO-CONSOLE

    MDR report key: 112407 · Received August 8, 1997

    Report

    Report Number
    2124837-1997-00016
    Event Type
    Malfunction
    Date Received
    August 8, 1997
    Date of Event
    July 7, 1997
    Report Date
    August 5, 1997
    Manufacturer
    MEDTRONIC BIO-MEDICUS, INC.
    Product Code
    DWA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HOSP REPORTED THAT THE BIO-CONSOLE'S FLOW DISPLAY INDICATED 9 L/M REGARDLESS OF THE ADJUSTMENT MADE TO THE UNIT'S RPM. BIO-CONSOLE HAD TO BE RE-ZEROED TO CORRECT THE FLOW DISPLAY READINGS. THE DEVICE WAS REMOVED FROM THE CIRCUIT AND REPLACED WITH A SECOND BIO-CONSOLE. CASE 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 CONTROLLER DWA MEDTRONIC BIO-MEDICUS, INC. 540 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other