TORNADO

Additional Manufacturer Narrative

INSPECTION OF THE DEVICE AND REVIEW OF PHOTOGRAPHIC EVIDENCE IDENTIFIED DAMAGE TO THE FLUSHER, WITH SEVERAL COMPONENTS EXHIBITING HEAT DAMAGE AND MELTING. AN ARJO SERVICE TECHNICIAN OBSERVED SMOLDERING INSIDE THE SOLENOID VALVE. PHOTOGRAPHIC DOCUMENTATION INDICATED THAT THE PHASE PIN HAD BEEN TORN OUT OF THE VALVE. THE ISSUE WAS REVIEWED IN CONSULTATION WITH THE MANUFACTURER TO ASSESS POTENTIAL CAUSES OF THE REPORTED INCIDENT. ONE POSSIBLE SCENARIO IS THAT THE TORN-OUT PHASE PIN RESULTED IN 230 V BEING PRESENT AT AN UNINSULATED TERMINAL. CONTACT WITH ANOTHER CONDUCTIVE COMPONENT COULD HAVE LED TO A SHORT CIRCUIT AND SUBSEQUENT IGNITION. ALTERNATIVELY, IF THE PHASE PIN WAS DISLODGED AS A RESULT OF THE INCIDENT, A CONTRIBUTING FACTOR MAY HAVE BEEN SIGNIFICANT LIMESCALE BUILDUP WITHIN THE VALVE. THIS COULD HAVE PROLONGED THE WATER FILLING PROCESS AND, IN COMBINATION WITH VISIBLE RUST OR LIMESCALE DEPOSITS ON THE PINS POTENTIALLY ACTING AS INSULATION, LED TO ELEVATED TEMPERATURES. IF THE VALVE REMAINED OPEN FOR AN EXTENDED PERIOD WITH CONTINUOUS CURRENT SUPPLY, THE TEMPERATURE COULD HAVE INCREASED TO A LEVEL SUFFICIENT TO CAUSE MATERIAL DEGRADATION, MELTING, AND SMOLDERING. THE TORNADO FLUSHER INVOLVED IN THE EVENT HAD BEEN IN USE FOR APPROXIMATELY 13 YEARS. AVAILABLE INFORMATION INDICATES THAT THE DEVICE HAD NOT BEEN SERVICED BY ARJO AND HAD NOT UNDERGONE PERIODIC MAINTENANCE. ACCORDING TO THE TORNADO USER MANUALS (6001314002): "PERIODIC MAINTENANCE AND SYSTEM TESTING MUST BE PERFORMED TO ENSURE SAFETY AND THE MACHINE'S PROPER OPERATION." OPERATION OF THE DEVICE WITHOUT APPROPRIATE MAINTENANCE MAY CONTRIBUTE TO DEVICE MALFUNCTION. PROGRESSIVE CORROSION AND LIMESCALE ACCUMULATION ON COMPONENTS OVER TIME, INCLUDING SOLENOID VALVE PINS, MAY DEGRADE THE QUALITY OF ELECTRICAL CONTACT AT PLUG-IN TERMINALS. SUCH DEGRADATION CAN RESULT IN AN UNSTABLE ELECTRICAL CONNECTION (E.G., INCREASED RESISTANCE OR INTERMITTENT CONTACT), WHICH MAY LEAD TO LOCALIZED OVERHEATING. THEREFORE, AGEING AND LACK OF REGULAR DEVICE MAINTENANCE CAN BE CONSIDERED POTENTIAL CONTRIBUTING FACTORS TO SUBSEQUENT ELECTRICAL MALFUNCTION. BASED ON THE AVAILABLE INFORMATION AND THE EVALUATION PERFORMED, THE FIRE MAY HAVE BEEN ASSOCIATED WITH EITHER EXPOSURE OF AN UNINSULATED LIVE COMPONENT DUE TO MECHANICAL DAMAGE OF THE SOLENOID VALVE OR THERMAL EFFECTS RELATED TO LIMESCALE BUILDUP WITHIN THE VALVE. BOTH SCENARIOS COULD RESULT IN OVERHEATING OR AN ELECTRICAL SHORT CIRCUIT, ULTIMATELY LEADING TO IGNITION OF THE DEVICE. DEVICE AGEING AND LACK OF MAINTENANCE MAY HAVE FACILITATED THE DEVELOPMENT OF THESE CONDITIONS AND ARE THEREFORE CONSIDERED CONTRIBUTING FACTORS. ARJO DEVICE FAILED TO MEET ITS PERFORMANCE SPECIFICATION. AS PER THE COLLECTED INFORMATION, NO INJURY OR OTHER HEALTH CONSEQUENCES WERE REPORTED TO BE A RESULT OF THIS EVENT. THE DEVICE WAS NOT BEING USED FOR THE TREATMENT OR DIAGNOSIS OF A PATIENT. THIS COMPLAINT WAS DECIDED TO BE REPORTED TO THE COMPETENT AUTHORITIES DUE TO ALLEGATION OF FIRE OCCURRENCE. H6. ANNEX G. CORRECTED.

Additional Manufacturer Narrative

PLEASE NOTE THAT PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED UNDER THE FOLLOWING REGISTRATION NUMBERS: 9616031, 3004147784, 3012068831. CURRENTLY, THESE PRODUCTS ARE TO BE HANDLED BY ARJOHUNTLEIGH AB¿S COMPLAINT HANDLING ESTABLISHMENT AND ANY MEDWATCH REPORTS WILL BE SUBMITTED UNDER REGISTRATION#: 3007420694. PROCESS OF ANALYZING INFORMATION IS ONGOING. ADDITIONAL INFORMATION WILL BE PROVIDED UPON CONCLUSION OF THE INVESTIGATION. NO UDI INFORMATION IS AVAILABLE; THE DEVICE WAS MANUFACTURED BEFORE UDI IMPLEMENTATION.

Description of Event or Problem

ARJO WAS NOTIFIED OF AN EVENT INVOLVING A TORNADO FLUSHER. IT WAS REPORTED THAT THE DEVICE WAS DAMAGED, WITH THE SOLENOID VALVE MELTING AND CATCHING FIRE. AN INSPECTION PERFORMED BY AN ARJO SERVICE TECHNICIAN CONFIRMED THAT SEVERAL COMPONENTS HAD BEEN AFFECTED BY HEAT AND HAD MELTED. NO INJURIES WERE REPORTED.