BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEKA MOTUS AX

    MDR report key: 18652344 · Received February 6, 2024

    Report

    Report Number
    3001431138-2024-00002
    Event Type
    Malfunction
    Date Received
    February 6, 2024
    Date of Event
    January 6, 2024
    Report Date
    February 6, 2024
    Manufacturer
    EL.EN. ELECTRONIC ENGINEERING S.P.A.
    Product Code
    GEX
    PMA / PMN Number
    K162886
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    WE THE MANUFACTURER OF THE DEVICE PERFORMED OUR OWN INVESTIGATION, BASED ON THE DATA AND PICTURES DISCLOSED BY THE FRENCH DISTRIBUTOR WHICH ARE THE FOLLOWING: THE PICTURES AND VIDES HAS BEEN ANALYZED IN ORDER TO EVALUATE THE MOST PROBABLE CAUSE OF THE FIRE. IN THE PICTURES AND VIDEO SHARED IS POSSIBLE TO SEE THAT THE DEVICE IS MOSTLY BURNED AND THAT THE FIRE HAS DEVELOPED MAINLY ON THE FRONT-LOWER SIDE OF IT. IN THAT AREA THERE ARE THE HIGH VOLTAGE POWER SUPPLY AND THE CONDENSERS BANK. THOSE HAVE BEEN EVALUATED AS THE MOST PROBABLE COMPONENTS THAT COULD HAVE GOT A MALFUNCTION AND IGNITED THE FIRE. ANYWAY, IT IS NOT CLEAR HOW THE FIRE COULD HAVE PROPAGATED SO FAST TO IGNITE IN MINUTES AND GET OUT OF CONTROL. IN FACT, PER THE NARRATIVE PROVIDED, IMMEDIATELY AFTER THE CRACKING NOISES THE DEVICE IMMEDIATELY TURNED OFF. THEN THE TENSION HAS BEEN TURNED OFF BY THE ASSISTANT FROM THE BUILDING CIRCUIT BRAKER. ALL THE CABLES OF THE DEVICE, AS WELL AS ALL THE EXTERNAL COVERS, ARE MADE OF SELF-EXTINGUISHING/FIRE RESISTANT MATERIAL (IN ACCORDANCE WITH IEC STANDARD 60601). A DEVICE OF THE SAME FAMILY OF THE ONE INVOVLED IN THE EVENT, SPECIFICALLY THE MOTUS AZ/AZ+, THAT HAVE ALMOST THE SAME ARCHITECTURE AND ELECTRICAL STRUCTURE, IS ALSO MARKED WITH THE CTUVUS SAFETY MARK IN THE USA. THIS MARK HAVE EVEN MORE STRICT REQUIREMENTS FOR FIRE PREVENTION AND PROTECTION. IN THE PICTURES SHARED THERE ARE ALSO A WALL-MOUNTED AIR CONDITIONER THAT TOOK FIRE (TOTALLY MELTED AND BURNED IN THE PICTURES) BUT HAVE NOTHING TO SHARE OR RELATE WIHT THE LASER. MOREOVER, A PICTURE OF BUILDING CIRCUIT-BRAKER, WITHOUT THE FRONT PANEL, HAS BEEN SHARED IN WHICH IT IS EVIDENT THE PRESENT OF SOOT INSIDE THE BOX WITHOUT ANY SIGN OF BURNS ON THE OUTSIDE WALL. PICTURES OF THE WALL-OUTLET WHERE THE DEVICE WAS SUPPOSEDLY CONNECTED HAS BEEN ALSO SHARED. IN THESE PICTURES IS POSSIBLE TO NOTE THAT THE PLUG HAS BEEN TEARED DOWN FROM THE WALL (EXPOSED ELECTRICAL CABLE FORM THE WALL-BOX). IT IS NOT CLEAR WHEN THE SOCKET HAS BEEN TEARED-DOWN AND FROM WHOM. FINALLY PICTURES OF AN IBM UNINTERRUPTIBLE POWER SUPPLY (UPS) HAS BEEN SHARED. IT SEEMS THAT THIS WAS PLACED ON A DIFFERENT ROOM THAT WAS NOT TOUCHED BY THE FIRE. IT IS NOT CLEAR IF SUCH UPS WAS USED TO POWER THE LASER. USAGE OF UPS TO SUPPLY THE LASER IS FORBIDDEN, AS REPORTED ON THE DEVICE OPERATOR'S MANUAL CODE OM112A1_G.V16 (ACTUAL REVISION SHIPPED WITH THE DEVICE), IN ORDER TO AVOID DAMAGES TO THE DEVICE. CONCERNING THE BUILDING POWER SUPPLY, WE HAVE NOT RECEIVED ANY INFORMATION ABOUT IT (POWER LINE /ELECTRICAL WIRING SPECIFICATIONS AND ITS CERTIFICATION) DESPITE SEVERAL ATTEMPTS. IN FACT, THIS ASPECT COULD BE CRUCIAL FOR THE DETERMINATION OF THE CAUSE OF THE EVENT. BASED ON THE INFORMATION AVAILABLE IT IS NOT POSSIBLE TO EXACTLY DETERMINE THE ROOT CAUSE OF THE EVENT. ANYWAY, MORE THAN 4000 DEVICES WITH SIMILAR HVPS AND CONDENSERS BANKS HAS BEEN PLACED ON THE MARKET (SINCE 2016 UP TO KNOW - BELONGING TO THE DEVICE'S FAMILIES MOTUS AX, MOTUS AY AND MOTUS AZ) AND NO OTHER SIMILAR EVENT HAS EVER BEEN RECORDED. BASED ON THE VERY LOW PROBABILITY OF THE EVENT (B)(4) AND THE FACT THAT IT IS NOT POSSIBLE TO DETERMINE IF A DEVICE'S MALFUNCTION IS ACTUALLY THE CAUSE OF THE FIRE (CONDITION ASSUMED ON THE SIDE OF CAUTION) WE DECIDED THAT NO CORRECTIVE ACTION/PREVENTIVE ACTION/FSCA IS REQUIRED: NO DESIGN DEFICIENCY IDENTIFIED AS ROOT CAUSE OF THE EVENT. THE PRESENT INITIAL REPORT HAS TO BE CONSIDERED AS A FINAL REPORT UNLESS FDA HAS FURTHER QUESTIONS. A FOLLOW-UP REPORT WILL BE PREPARED AND SUBMITTED IN CASE ANY RELEVANT INFORMATION WILL ARISE.

    Description of Event or Problem · 0

    ON (B)(6) 2024, (B)(6) BECAME AWARE OF AN EVENT, REPORTED BY THE FRENCH/NORTH AFRICA DISTRIBUTOR, IN WHICH THEY INFORMED US OF AN EVENT WHERE THE MEDICAL DEVICE MOTUS AX IGNITED AND TOOK FIRE INSIDE THE CLINIC. THE EVENT TOOK PLACE AT DR. (B)(6) CLINIC PLACED IN (B)(6). THE ACTUAL DEVICE INVOLVED IN THE EVENT IS A MEDICAL DEVICE AND IS NOT MARKETED IN THE US. ANYWAY, A SIMILAR MEDICAL DEVICE MOTUS AX WITH REF: (B)(4) IS MANUFACTURED BY EL.EN. ELECTRONIC ENGINEERING SPA AND MARKETED IN THE US WITH 510(K) K162886. IN THE COMMUNICATION IT IS REPORTED THAT NO PATIENT OR OPERATOR GOT INJURED DURING THE EVENT. THE INFORMATION GATHERED, ABOUT THE EVENT ARE THE FOLLOWING: THE NARRATIVE PROVIDED BY THE CLINIC REPORTS THAT, IN DATE (B)(6) 2024, THE LASER ASSISTANT STARTED TO WORK AT 9:15 AM BY TURNING ON THE DEVICE. 10 MINUTES LATER SHE INITIATES A TREATMENT ON THE PATIENT. A FEW SECONDS LATER THE LASER MADE CRACKING NOISES AND TURNED OFF IMMEDIATELY. THE ASSISTANT THAN PROCEEDED TO DIRECTLY TURN OFF THE ELECTRICITY FROM THE BUILDING CIRCUIT-BRAKER. THE LASER STARTED TO SMOKE (IT IS NOTED THAT THE SMOKE WAS COMING OUT FROM THE DEVICE'S SIDE AIR-VENTS) AND WITHIN MINUTES THE FIRE WAS OUT OF CONTROL AND REQUIRE THE INTERVENTION OF THE FIREFIGHTERS (ASSISTANT TRIED TO PUT OUT THE FIRE WITH A FIRE EXTINGUISHER WITHOUT SUCCESS). WE, THE MANUFACTURER OF DEVICE, BECAME AWARE OF THE EVENT ON JANUARY THE 8TH 2024 BY SPECIFIC COMMUNICATION OF THE FRENCH DISTRIBUTOR, AND EVALUATED THE EVENT REPORTABLE BECAUSE, ACCORDING TO FDA 21 CFR PART 803 THIS IS A MALFUNCTION THAT COULD LEAD TO SERIOUS INJURIES IN CASE IT WILL RECUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495718 DEKA MOTUS AX DEKA MOTUS AX GEX EL.EN. ELECTRONIC ENGINEERING S.P.A. M112A1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown