BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO ECHO

    MDR report key: 4152932 · Received October 8, 2014

    Report

    Report Number
    1034569-2014-00177
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    September 11, 2014
    Report Date
    October 8, 2014
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK070016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IMMUCOR FIELD SERVICE ENGINEER VISITED CUSTOMER SITE ON (B)(6) 2014 AND DETERMINED THAT THE INSTRUMENT HAD PINCHED TUBING BETWEEN THE FLUIDICS AND MAIN MODULES, AS WELL AS THE PERISTALTIC TUBING WAS COMPLETELY DISFORMED, ALL OF WHICH CONTRIBUTED TO UNEXPECTED OUTCOMES.

    Description of Event or Problem · 1

    ON (B)(6) 2014, A CUSTOMER REPORTED AN UNEXPECTED (B)(6) RESULT WHEN TESTING A BLOOD SAMPLE ON A GALILEO ECHO. EVENT HAPPENED IN ((B)(6)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632045 GALILEO ECHO AUTOMATED BLOOD BANK SYSTEM KSZ IMMUCOR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1