BEUDAMED
    FDA Adverse Event Other Summary report: N

    FREEDOM EVO 150

    MDR report key: 3144982 · Received May 30, 2013

    Report

    Report Number
    3003402518-2013-00002
    Event Type
    Other
    Date Received
    May 30, 2013
    Date of Event
    April 30, 2013
    Report Date
    May 30, 2013
    Manufacturer
    TECAN SCHWEIZ AG
    Product Code
    JQW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE REPRESENTATIVE (FSE) EVALUATED THE INSTRUMENT AT THE CUSTOMER'S LABORATORY ON (B)(4) 2013. THE FSE WAS UNABLE TO REPRODUCE THE EVENT. WHEN THE FRONT PANEL DOOR WAS LIFTED ALL THE WAY OPEN AND SECURED IT DID NOT FALL. IF THE DOOR WAS PUSHED HALFWAY UP, IT FELL. A GAS SPRING IS ATTACHED TO THE DOOR PANEL AND THE INSTRUMENT. THE SPRING AIDS IN MAINTAINING PANEL IN AN UP POSITION AND IN CONTROLLING THE DESCENT. THE GAS SPRING WAS REPLACED AS A PRECAUTION AND RETURNED TO THE MANUFACTURER FOR FURTHER EVALUATION. THE GAS SPRING WAS TESTED AT (B)(4) MANUFACTURING FACILITY AND WAS FOUND TO MEET SPECIFICATIONS. THERE IS NO EVIDENCE OF MALFUNCTION.

    Description of Event or Problem · 1

    LABORATORY EMPLOYEE WAS PERFORMING DAILY MAINTENANCE ON INSTRUMENT WHEN THE FRONT PANEL DOOR FELL FROM THE OPEN POSITION WITH THE EDGE OF THE DOOR STRIKING EMPLOYEE'S FOREHEAD JUST ABOVE THE EYE. EMPLOYEE HAD A SMALL GASH THAT BLED AND WAS TREATED WITH BASIC FIRST AID (CLEANING) AND APPLICATION OF ANTIBIOTIC CREAM AND BAND AID). NO FURTHER MEDICAL ATTENTION WAS REQUIRED. THE EMPLOYEE INDICATED THE DOOR HAD FALLEN IN THE PAST BUT NO ONE WAS INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237888 FREEDOM EVO 150 PIPETTING STATION FOR CLINICAL USE JQW TECAN SCHWEIZ AG EVO 150

    Patients

    Seq Age Sex Outcome Treatment
    1