NINJO

Additional Manufacturer Narrative

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

Additional Manufacturer Narrative

IT WAS REPORTED THAT AFTER A FIRE IN THE POWER SUPPLY, THE NINJO FLUSHER STOPPED WORKING AND THE PLUG COULD NOT BE REMOVED FROM THE WALL SOCKET. THE WALL SOCKET AND THE PLUG TIP WERE BURNED. THE CIRCUIT BREAKERS/FUSES DID NOT TRIP. A LOCAL ELECTRICIAN REPLACED THE WALL SOCKET. HOWEVER, THE PLUG REMAINED STUCK IN THE OLD SOCKET AND COULD NOT BE REMOVED. NO INJURIES WERE REPORTED. THE FIRE WAS REPORTEDLY EXTINGUISHED USING A POWDER FIRE EXTINGUISHER. FOLLOWING THE EVENT, THE PLUG AND WALL OUTLET WERE REMOVED, AS BOTH COMPONENTS HAD MELTED TOGETHER AS A RESULT OF THE FIRE. A LOCAL ELECTRICIAN SUBSEQUENTLY INSTALLED A NEW WALL OUTLET. AN ARJO TECHNICIAN THEN REPLACED THE DEFECTIVE COMPONENTS, AND VERIFIED THE ELECTRICAL PARAMETERS. THE DEVICE WAS CONFIRMED TO OPERATE CORRECTLY FOLLOWING THESE CHECKS. ACCORDING TO THE ARJO TECHNICIAN, THE FIRE MOST LIKELY ORIGINATED AT THE WALL OUTLET. THE DEVICE INSPECTION, SUPPORTED BY THE PROVIDED PHOTOGRAPHS, SHOWED THAT THE NINJO FLUSHER WAS CONNECTED TO THE WALL USING A PLUG-AND-SOCKET CONNECTION. THIS TYPE OF CONNECTION IS NOT IN ACCORDANCE WITH THE INSTALLATION REQUIREMENTS SPECIFIED IN THE ASSEMBLY AND INSTALLATION INSTRUCTIONS FOR THE NINJO FLUSHER. THE DEVICE INVOLVED IN THIS COMPLAINT WAS INSTALLED BY A THIRD-PARTY COMPANY. ACCORDING TO THE ASSEMBLY AND INSTALLATION INSTRUCTIONS (6001313602_2_EN) FOR THE NINJO FLUSHER IS INTENDED TO BE INSTALLED AS PERMANENTLY CONNECTED(HARDWIRE) DEVICE. THE INSTRUCTIOS SPECIFY THE FOLLOWING REQUIREMENTS: ¿- INSTALL THE MACHINE IN ACCORDANCE WITH INSTALLATION CATEGORY CAT II. - MAKE A NOTCH FOR ELECTRICAL CABLES ON THE SIDE OF THE MACHINE. - FIT THE SUPPLIED CABLE BUSHING AND PULL THE CABLES THROUGH. - CONNECT THE MACHINE TO A SEPARATE ISOLATOR SWITCH APPROVED TO LOCAL STANDARDS, WHICH MUST BE MOUNTED ON THE WALL CLOSE TO THE MACHINE. (¿) - ALL CABLES MUST BE CLASSIFIED FOR AT LEAST 90°C." THESE REQUIREMENTS CLEARLY INDICATE THAT THE MANUFACTURER EXPECTS A HARDWIRED INSTALLATION. THE ISSUE WAS REVIEWED IN CONSULTATION WITH THE MANUFACTURER, WHO CONFIRMED THAT THE OBSERVED PLUG-AND-SOCKET CONNECTION DID NOT COMPLY WITH THE SPECIFIED INSTALLATION INSTRUCTIONS. ARJO FLUSHERS ARE CERTIFIED EXCLUSIVELY FOR HARDWIRED CONNECTIONS. ACCORDING TO THE MANUFACTURER, ALL INFORMATION OBTAINED INDICATES THAT THE PLUG CONNECTION WAS THE CAUSE OF THE OVERHEATING, PARTICULARLY AS THE BURNING ORIGINATED AT THIS LOCATION. BASED ON THIS ASSESSMENT, THE NON-COMPLIANT INSTALLATION WAS IDENTIFIED AS THE MOST LIKELY CAUSE OF THE REPORTED FIRE. APPROPRIATE ACTIONS HAVE BEEN INITIATED TO ADDRESS THE IDENTIFIED ISSUE AND MITIGATE THE RISK OF RECURRENCE. IN SUMMARY, IT WAS CONCLUDED THAT THE REPORTED FIRE RESULTED FROM A NON-PERMITTED INSTALLATION OF THE NINJO FLUSHER USING A PLUG-AND-SOCKET CONNECTION INSTEAD OF THE REQUIRED PERMANENT HARDWIRED CONNECTION. THIS IMPROPER INSTALLATION LED TO OVERHEATING, WHICH ULTIMATELY CONTRIBUTED TO THE REPORTED INCIDENT. THE NINJO FLUSHER WAS NOT UP TO THE MANUFACTURER¿S SPECIFICATION DUE TO INCORRECT ELECTRICAL CONNECTION PERFORMED (PLUG-AND-SOCKET CONNECTION). THE COMPLAINT WAS DECIDED TO BE REPORTED TO THE COMPETENT AUTHORITIES DUE TO ALLEGATION OF FIRE OCCURRENCE. THERE WAS NO PATIENT INVOLVEMENT, AND NO INJURIES WERE REPORTED.

Additional Manufacturer Narrative

THE DEVICE INSPECTION, TOGETHER WITH THE PHOTOS PROVIDED, INDICATED THAT THE NINJO FLUSHER WAS CONNECTED TO THE WALL USING A PLUG-AND-SOCKET CONNECTION, WHICH IS NOT IN ACCORDANCE WITH THE INSTALLATION REQUIREMENTS SPECIFIED IN THE ASSEMBLY AND INSTALLATION INSTRUCTIONS FOR THE NINJO FLUSHER. THE PROCESS OF COLLECTING AND ANALYZING ADDITIONAL INFORMATION IS ONGOING. ADDITIONAL INFORMATION WILL BE PROVIDED UPON COMPLETION OF THE INVESTIGATION.

Additional Manufacturer Narrative

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

Additional Manufacturer Narrative

IT WAS DETERMINED THAT THE FIRE MOST LIKELY ORIGINATED IN THE SOCKET, WHERE THE POWER CORD HAD NOT BEEN PROPERLY TIGHTENED, RESULTING IN HIGH CONTACT RESISTANCE. AFTER THE LOCAL ELECTRICIAN INSTALLED A NEW SOCKET, THE DEVICE WAS INSPECTED BY AN ARJO REPRESENTATIVE, WHO SHORTENED THE CABLE, INSTALLED A NEW PLUG, AND CHECKED THE ELECTRICAL VALUES USING AN MDTEST DEVICE. EVERYTHING WAS FUNCTIONING PROPERLY. PROCESS OF ANALYZING INFORMATION IS ONGOING. ADDITIONAL INFORMATION WILL BE PROVIDED UPON INVESTIGATION CONCLUSION. THE DEVICE IS DISTRIBUTED OUTSIDE THE US AND NO GUDID INFORMATION EXISTS. UDI: (B)(4).

Description of Event or Problem

ARJO RECEIVED A COMPLAINT REGARDING THE NINJO FLUSHER. IT WAS REPORTED THAT AFTER A MINOR FIRE IN THE POWER SUPPLY, THE DEVICE STOPPED WORKING AND COULD NOT BE REMOVED FROM THE WALL SOCKET. THE WALL SOCKET AND THE PLUG TIP WERE BURNED. THE CIRCUIT BREAKERS/FUSES DID NOT TRIP. A LOCAL ELECTRICIAN REPLACED THE WALL SOCKET. HOWEVER, THE PLUG REMAINED STUCK IN THE OLD SOCKET AND COULD NOT BE REMOVED. NO INJURIES WERE REPORTED.