BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREEDOM EVO-2 100

    MDR report key: 2834953 · Received November 9, 2012

    Report

    Report Number
    3003402518-2012-00001
    Event Type
    Malfunction
    Date Received
    November 9, 2012
    Date of Event
    October 14, 2012
    Report Date
    November 8, 2012
    Manufacturer
    TECAN SCHWEIZ AG
    Product Code
    JQW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TECAN EVALUATED THE LIQUID HANDLING ARM NOTING THAT THE TANTAL CONDENSER CAPACITOR C41 OVERHEATED WHICH RESULTED IN SMOKE DEVELOPMENT AND DESTRUCTION OF PCB BOARDS. THE ASSEMBLY HAS BEEN SENT TO SUPPLIER FOR FURTHER INVESTIGATION. THE RESULTS FROM THAT INVESTIGATION WILL BE DOCUMENTED IN A FOLLOW UP REPORT. THIS APPEAR TO BE AN ISOLATED EVENT. THERE WAS NO FACILITY DAMAGE OR INJURY TO ANY LABORATORY PERSONNEL.

    Description of Event or Problem · 1

    TECAN WAS NOTIFIED BY DISTRIBUTOR IN (B)(6) OF AN ERROR WHERE THE LIQUID HANDLING ARM ON THE EVO 100 COLLIDED WITH THE WASH STATION DURING MOVEMENT ALONG THE X AXIS. OPERATOR REPORTED A SPARK FROM THE BACK OF THE LIQUID HANDLING ARM AND INSTRUMENT WAS SHUT DOWN. THERE WAS NO INJURY TO ANY PERSONNEL OR DAMAGE TO THE FACILITY. EVO INSTRUMENT WAS NO LONGER OPERATIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREEDOM EVO-2 100 PIPETTING STATION FOR CLINICAL USE JQW TECAN SCHWEIZ AG EVO-2 100

    Patients

    Seq Age Sex Outcome Treatment
    1 Other