BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC BIOMEDICUS

    MDR report key: 165116 · Received April 15, 1998

    Report

    Report Number
    165116
    Event Type
    Injury
    Date Received
    April 15, 1998
    Date of Event
    April 13, 1998
    Report Date
    April 15, 1998
    Manufacturer
    MEDTRONIC CARDIAC SURGERY SERVICE
    Product Code
    DTQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    BIOMEDICUS PUMP DECREASED IN SPEED (RPM) DURING A CARDIOPULMONARY BYPASS. REQUIRED HAND CRANK AND CHANGE TO ROLLER HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC BIOMEDICUS CARDIOPULMONARY BYPASS DTQ MEDTRONIC CARDIAC SURGERY SERVICE 540 *

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization