TYPHOON

Additional Manufacturer Narrative

THE DEVICE WAS INSPECTED BY ARJO. IT WAS DETERMINED THAT THE STEAM GENERATOR WAS FAULTY. THE DEVICE WAS REMOVED FROM SERVICE. THE CUSTOMER IS CONSIDERING REPLACING THE TYPHOON DUE TO THE AGE OF THE UNIT. PROCESS OF ANALYZING INFORMATION IS ONGOING. ADDITIONAL INFORMATION WILL BE PROVIDED UPON INVESTIGATION CONCLUSION. 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. NO UDI INFORMATION IS AVAILABLE, THE DEVICE WAS MANUFACTURED BEFORE UDI IMPLEMENTATION.

Description of Event or Problem

ARJO WAS NOTIFIED OF AN INCIDENT INVOLVING A TYPHOON FLUSHER, IN WHICH IT WAS INDICATED THAT THE FLUSHER HAD CAUGHT FIRE. AN ELECTRICAL BURNING SMELL WAS COMING FROM THE DEVICE, THE FIRE DEPARTMENT WAS CALLED, AND THE UNIT WAS DISCONNECTED FROM POWER. NO ONE WAS INJURED OR HARMED AS A RESULT OF THE INCIDENT.

Additional Manufacturer Narrative

IT WAS REPORTED THAT THE FLUSHER HAD CAUGHT FIRE. AN ELECTRICAL BURNING SMELL WAS COMING FROM THE DEVICE, THE FIRE DEPARTMENT WAS CALLED, AND THE UNIT WAS DISCONNECTED FROM POWER. NO ONE WAS INJURED OR HARMED AS A RESULT OF THE INCIDENT. THE DEVICE INSPECTION AND THE PHOTO EVIDENCE SHOWED THAT THE STEAM GENERATOR OF THE TYPHOON FLUSHER WAS LEAKING AND DEFORMED. IT WAS ALSO NOTED THAT THERE WAS A SMELL OF ELECTRICAL BURNING. THE SERVICE HISTORY OF THE DEVICE SHOWED THAT THE STEAM GENERATOR HAD BEEN REPLACED SINCE MANUFACTURING, IN MAY 2023, WHICH MEANS IT WAS EQUIPPED WITH A MANUAL RESET ASSOCIATED WITH THE THERMAL PROTECTION IMPROVEMENT. ADDITIONALLY, ONE MONTH BEFORE THE EVENT, THE TYPHOON HAD EMITTED A BURNING SMELL. HOWEVER, THE DEVICE INSPECTION PERFORMED BY ARJO AND THE TESTS CARRIED OUT AT THAT TIME SHOWED NO ANOMALIES, AND NO FAULT WAS IDENTIFIED. THE ISSUE WAS CONSULTED WITH THE PRODUCT ENGINEERING MANAGER, AND IT WAS CONCLUDED THAT THERE WAS NOT ENOUGH WATER IN THE STEAM GENERATOR. THE CAUSE WAS LIKELY LEAKAGE AND POSSIBLY LIMESCALE BUILDUP IN THE PIPING, WHICH REMAINED OLD DESPITE THE PREVIOUS REPLACEMENT OF THE STEAM GENERATOR (THE DEVICE WAS MANUFACTURED IN SEPTEMBER 2008). THE BURNING SMELL REPORTED A MONTH EARLIER MAY ALREADY HAVE BEEN A SIGN THAT SOMETHING WAS WRONG. HOWEVER, THE DEVICE DID NOT DISPLAY ANY ERROR CODES. IT CANNOT BE RULED OUT THAT THE ERROR CODES WERE CLEARED, BUT THIS COULD NOT BE CONFIRMED. THE INVESTIGATION PERFORMED BY MANUFACTURER CONFIRMED THAT LEAKAGE FROM THE STEAM GENERATOR CAN CAUSE A SHORT CIRCUIT IN THE ELECTRICAL COMPONENTS, WHICH MAY RESULT IN THERMOSTAT FAILURE (PART OF THE STEAM GENERATOR) AND LEAD TO ELEVATED TEMPERATURES INSIDE THE STEAM GENERATOR. THIS FAULT OCCURS INTERMITTENTLY AND IS INFLUENCED BY VARIOUS FACTORS, INCLUDING PRODUCT MAINTENANCE, CORRECTNESS OF CONNECTIONS, AND WATER QUALITY. IN SOME CASES, LEAKAGE MAY LEAD TO DEVICE IGNITION, MELTING OF COMPONENTS, BURNING, OR SMOKING. ACCORDING TO THE TYPHOON INSTRUCTION FOR USE (6001268502), PERIODIC MAINTENANCE AND SYSTEM TESTING MUST BE PERFORMED TO ENSURE SAFETY AND PROPER OPERATION OF THE MACHINE. FOR THE STEAM GENERATOR¿EVERY YEAR / 7,500 CYCLES¿THE IFU REQUIRES THE FOLLOWING CHECKS: ¿CHECK THE CONNECTIONS TO THE STEAM GENERATOR FOR LEAKAGE AND MAKE SURE THE SURROUNDING INSULATION IS INTACT AND NO HOT SURFACES ARE EXPOSED.¿ ¿CHECK THAT THE STEAM GENERATOR IS WORKING PROPERLY.¿ AS A RESULT OF THE INVESTIGATION, IT WAS DETERMINED THAT THE REPORTED DEVICE IGNITION COULD POTENTIALLY BE ASSOCIATED WITH LEAKAGE IN THE PIPING CAUSED BY WEAR, WHICH MAY LEAD TO THERMOSTAT FAILURE AND SUBSEQUENT HIGH TEMPERATURES INSIDE THE STEAM GENERATOR. 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.

Additional Manufacturer Narrative

PROCESS OF COLLECTING AND ANALYZING INFORMATION IS ONGOING. ADDITIONAL INFORMATION WILL BE PROVIDED UPON INVESTIGATION CONCLUSION.