BEUDAMED
    FDA Adverse Event Other Summary report: N

    MIXER OEM SHILEY

    MDR report key: 833853 · Received March 6, 2007

    Report

    Report Number
    2020676-2007-00003
    Event Type
    Other
    Date Received
    March 6, 2007
    Date of Event
    December 18, 2006
    Report Date
    March 6, 2007
    Manufacturer
    SECHRIST INDUSTRIES, INC.
    Product Code
    BZR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MIXER BEING RETURNED FOR EVALUATION. WAS USED DURING INCIDENT INVOLVING BYPASS PROCEDURE PER RECEIVED FDA MEDWATCH REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIXER OEM SHILEY AIR / OXYGEN MIXER BZR SECHRIST INDUSTRIES, INC. 3500CP-S *

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR