BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEQUESTRA 1000

    MDR report key: 2933242 · Received December 28, 2012

    Report

    Report Number
    2933242
    Event Type
    Malfunction
    Date Received
    December 28, 2012
    Date of Event
    September 8, 2012
    Report Date
    December 28, 2012
    Manufacturer
    MEDTRONIC BIOMEDICUS
    Product Code
    CAC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING PROCEDURE THE CELL-SAVER WAS NOT FUNCTIONING. THE MONITOR WAS NOT WORKING, WHICH CAUSED A DELAY IN THE BLOOD TRANSFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEQUESTRA 1000 APPARATUS, AUTOTRANSFUSION CAC MEDTRONIC BIOMEDICUS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR