BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEKA SYNCHRO REPLA: Y ONE 0.7

    MDR report key: 3888157 · Received April 17, 2014

    Report

    Report Number
    3001431138-2014-00001
    Event Type
    Malfunction
    Date Received
    April 17, 2014
    Date of Event
    March 3, 2014
    Report Date
    April 17, 2014
    Manufacturer
    EL.EN. ELECTRONIC ENGINEERING S.P.A
    Product Code
    GEX
    PMA / PMN Number
    K131095
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ON THE BASIS OF FEW AVAILABLE REPORTED INFORMATION, IT IS NOT POSSIBLE TO DETERMINE WHETHER THE DEVICE MALFUNCTIONED AND CAUSED OR CONTRIBUTED TO CAUSE THE FIRE AND WHETHER IT COULD LEAD TO ADVERSE EVENT IF THE EVENT RECUR. SUSPECTED BURNED DEVICE IS GOING TO BE RETURNED TO MANUFACTURER FACILITY FOR INVESTIGATION. CUSTOMER ALREADY CONFIRMED AVAILABILITY TO RETURN THE DEVICE FOR AN INDEPENDENT EXPERT ANALYSIS IN (B)(6) TERRITORY. REPORT OF (B)(6) FIRE SPECIALIST HAS BEEN ALREADY MADE AVAILABLE BY CUSTOMER IN (B)(6) LANGUAGE. THIS REPORT IS CURRENTLY UNDER TRANSLATION. EVEN THOUGH THE EVENT IS NOT YET CONFIRMED AS REPORTABLE ADVERSE EVENT (ASSESSMENT NOT POSSIBLE; DEVICE ASSUMED TO BE CONTRIBUTORY CAUSE OF THE EVENT ON SIDE OF CAUTION), THIS INITIAL REPORT IS SUBMITTED ANYWAY WITHIN DUE DATE (30 CALENDAR DAYS FROM MANUFACTURER AWARENESS DATE). A FOLLOW-UP OR FINAL REPORT WILL BE SUBMITTED ONCE THE TECHNICAL EVALUATION OF RETURNED SUSPECTED DEVICE AND THE INVESTIGATION ON CLINIC ELECTRICAL SYSTEM (WIRING) CONFORMITY ARE COMPLETED BY MANUFACTURER. NOTE: FOLLOWING (B)(6), A REPORT ABOUT THIS EVENT WAS ALSO SENT TO (B)(6) ON (B)(4) 2014.

    Description of Event or Problem · 1

    A FOREIGN DISTRIBUTOR REPORTED US ABOUT A CUSTOMER THAT HAD A FIRE AT CLINIC IN THE ROOM WHERE STOOD A MEDICAL LASER DEVICE MODEL "SYNCHRO REPLA: Y ONE 0.7" MANUFACTURED BY EL EN ELECTRONIC ENGINEERING (B)(4). EVENT OCCURRED AT (B)(6). DISTRIBUTOR REPORTED THAT THE FIRE STARTED AT NIGHT WHEN THE DEVICE WAS SWITCHED OFF (NOT IN USE). NO PEOPLE PRESENT AT THE TIME OF EVENT. BY REPORT OF FIREFIGHTERS INTERVENED AT THE CLINIC, THE FIRE SEEMS BEGUN IN THE PLACE WHERE THE DEVICE STOOD. THIS FACT IS TO BE VERIFIED. NO PATIENTS OR OPERATORS INVOLVED. NO INJURIES TO OTHER PERSONS. DAMAGES ARE LIMITED TO PROPERLY AND GOODS. DEVICE HAS BEEN PARTIALLY DESTROYED BYE THE FIRE. WE, THE MANUFACTURER OF DEVICE, BECAME AWARE OF THE EVENT ON (B)(4) 2014 BY EMAIL FROM (B)(6) LOCAL DISTRIBUTOR, (B)(6) COMPANY LOCATED IN (B)(6). SUBSEQUENTLY, WE HAVE BEEN INFORMED THAT THE EVENT OCCURRED ON (B)(6) 2014. INVOLVED DEVICE IS SIMILAR TO DEVICE MODEL "SYNCHRO REPLA: Y EXCELLIUM/PREMIUM" MANUFACTURED BY THE COMPANY AND MARKETED IN USA TERRITORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236222 DEKA SYNCHRO REPLA: Y ONE 0.7 GEX EL.EN. ELECTRONIC ENGINEERING S.P.A M104A1

    Patients

    Seq Age Sex Outcome Treatment
    1