Description of Event or Problem · 0
MDR NUMBER:1000143485-2025-28077. ADDITIONAL MANUFACTURER NARRATIVE: REACHED OUT TO CUSTOMER, ON MULTIPLE OCCASIONS REQUESTING ADDITIONAL INFORMATION.PHOTOS WERE RECEIVED OF UNIT AND NO DAMAGE WAS OBSERVEDINDICATING UNIT DID NOT EXPLODE BUT THAT HOT WATER POPPED. EVENT OR PROBLEM DESCRIPTION. CUSTOMER INDICATED WHILE THEY WERE USING THE UNIT IT EXPLODED AND HOT WATER LANDED ON HER CHIN CAUSING A BURN. CAUSE ANALYSIS: 5.1. ACCORDING TO THE CUSTOMER COMPLAINT INFORMATION QUERY, THE PRODUCTION DATE OF THE CUSTOMER COMPLAINT PRODUCT IS NOVEMBER 26, 2021, AND IT HAS BEEN IN PRODUCTION FOR 4 YEARS, WHICH HAS EXCEEDED THE PRODUCT'S SERVICE LIFE. 5.2.AS THE DEFECTIVE PRODUCTS WERE NOT RETURNED, VEGA CONDUCTED A POSSIBLE CAUSE ANALYSIS AND VERIFICATION BASED ON THE CUSTOMER'S DESCRIPTION. 5.2.1. ACCORDING TO THE INSTRUCTIONS, ONLY 25ML OF CLEAR WATER SHOULD BE ADDED TO THE HEATING CUP EACH TIME, AND 60ML OF CLEAR WATER SHOULD BE ADDED TO THE COLD-WATER TANK. SIMULATE WHETHER THERE IS HOT WATER SPURTING OUT AND SCALDING THE USER WHEN THE CONSUMER ADDS MORE THAN 25ML OF CLEAR WATER TO THE HEATING CUP OR FILLS IT UP. 5.2.1.1 SIMULATION VERIFICATION: FILL THE HEATING CUP WITH CLEAR WATER (ABOUT 70ML), AND ADD 60ML OF CLEAR WATER TO THE COLD-WATER TROUGH OF THE WATER CUP. VERIFICATION RESULT: THE WATER IN THE COLD-WATER TROUGH OF THE WATER CUP WAS SPRAYED OUT FIRST, AND THERE WAS STILL BOILING WATER REMAINING IN THE HEATING CUP. THE PRODUCT CONTINUED TO WORK, AND THE SPRAYED BOILING WATER WAS NOT NEUTRALIZED BY COLD WATER. VEGA MONITORED THE STEAM TEMPERATURE. WHEN USING THE SMALL MASK, THE TEMPERATURE WASTHE TEMPERATURE IS 56.2[?] , AND THE MAXIMUM TEMPERATURE WHEN USING A LARGE MASK IS 54.5[?], WHICH MAY CAUSE DISCOMFORT TO CONSUMERS. 5.2.2 ACCORDING TO THE INSTRUCTIONS, ADD 60ML OF CLEAR WATER TO THE COLD-WATER TROUGH. SIMULATE THE SITUATION WHERE A CONSUMER ADDS LESS THAN 60ML OF CLEAR WATER TO THE COLD-WATER TROUGH OF A WATER CUP TO SEE IF HOT WATER SPURTS OUT AND SCALDS THE USER. 5.2.2.1. SIMULATION VERIFICATION: ADD 25ML OF CLEAR WATER TO THE HEATING CUP AND 10ML OF CLEAR WATER TO THE COLD-WATER TROUGH OF THE WATER CUP. VERIFICATION RESULT: THE WATER IN THE COLD-WATER TROUGH OF THE WATER CUP HAS BEEN SPRAYED OUT FIRST. THERE IS STILL SOME BOILING WATER LEFT IN THE HEATING CUP. THE PRODUCT CONTINUES TO WORK. THE BOILING WATER SPRAYED OUT HAS NOT BEEN NEUTRALIZED BY COLD WATER. VEGA MONITORS THE STEAM TEMPERATURE AND THE TEMPERATURE WHEN USING THE SMALL MASKTHE TEMPERATURE IS 53.2[?] , AND THE MAXIMUM TEMPERATURE WHEN USING A LARGE MASK IS 52[?]. THIS MAY CAUSE DISCOMFORT TO CONSUMERS, BUT THE USER HAS BEEN USING THIS PRODUCT FOR 29 MONTHS AND IT IS IMPOSSIBLE FOR SUCH A PROBLEM TO OCCURIMPROPER OPERATION LED TO THE OCCURRENCE OF SCALDING INCIDENTS. RULE OUT THIS POSSIBILITY. 5.2.3 A SIMULATED CONSUMER ADDED INCENSE, MEDICINE OR OTHER CHEMICAL REAGENTS TO THE HEATING CUP TO VERIFY THAT THE CHEMICALS REACTED CHEMICALLY WITH THE SEALING COVER, CAUSING THE SEALING COVER TO BECOME BRITTLE AND CRACK, FAIL, AND THE HOT STEAM INSIDE THE HEATING CUP SPRAYED OUT AND SCALDED THE CONSUMER. 5.2.3 VERIFICATION RESULT[?] SIMULATION 5.5 WAS USED FOR TEST VERIFICATION. THE PRODUCT WAS OPERATED WITH HYDROGEN PEROXIDE FOR 245 TIMES, FEISOFENA TABLETS FOR 232 TIMES, AND DEXAMETHASONE FOR 263 TIMES. THERE WERE CORROSION AND CRACKING PHENOMENA ON THE SURFACE OF THE PRODUCT'S SEALING COVER. DURING THE TEST, THE SEALING COVER BECAME BRITTLE AND CRACKED. THE HEATING CUPS WERE ALL WORN (AS SHOWN IN THE TEST REPORT IN ATTACHMENT 1). WATER VAPOR WAS SPRAYED OUT FROM THE HEATING CUPS. IT MAY CAUSE DISCOMFORT TO CONSUMERS. 5.2.4 AFTER THE SIMULATED CONSUMER'S USE, THE COLD-WATER HOLE OF THE NOZZLE WAS BLOCKED BY FOREIGN OBJECTS OR RESIDUAL LIQUID MEDICINE. IT WAS VERIFIED THAT THE NOZZLE COULD NOT DRAW IN COLD WATER, AND ONLY THE HOT STEAM IN THE HEATING CUP WAS SPRAYED OUT, SCALDING THE CONSUMER. 5.2.4. VERIFICATION RESULTS: THE COLD-WATER HOLE OF THE NOZZLE IS BLOCKED BY FOREIGN OBJECTS OR RESIDUAL LIQUID MEDICINE, WHICH PREVENTS THE NOZZLE FROM DRAWING IN COLD WATER. AS A RESULT, ONLY THE HOT STEAM IN THE HEATING CUP IS SPRAYED OUT. VEGA MONITORS THE STEAM TEMPERATURE. WHEN USING THE SMALL MASK, THE MAXIMUM TEMPERATURE IS 54.2[?]. WHEN USING A LARGE MASK, THE MAXIMUM TEMPERATURE IS 51.9[?], WHICH MAY CAUSE DISCOMFORT TO CONSUMERS. TEST RESULT: PUT 25ML OF WATER INTO THE HEATING CUP AND 60ML OF WATER INTO THE COLD-WATER TANK. VEGA MONITORS THE STEAM TEMPERATURE. WHEN USING THE SMALL MASK, THE MAXIMUM TEMPERATURE IS 40.4[?], AND WHEN USING THE LARGE MASK, THE MAXIMUM TEMPERATURE IS 37.5 [?]. IT WILL NOT CAUSE DISCOMFORT TO CONSUMERS. 5.3. SUMMARY WHEN INCENSE, MEDICINE OR OTHER CHEMICAL REAGENTS WERE ADDED TO THE HEATING CUP, THE SURFACE OF THE PRODUCT'S SEALING COVER SHOWED SIGNS OF CORROSION AND CRACKING. DURING THE TESTING PROCESS, THE SEALING COVER BECAME BRITTLE AND CRACKED. ALL THE HEATING CUPS WERE WORN OUT, AND WATER VAPOR WAS EJECTED FROM THE HEATING CUP, WHICH MIGHT CAUSE DISCOMFORT TO CONSUMERS IF THE COLD-WATER HOLES OF THE NOZZLE ARE BLOCKED BY FOREIGN OBJECTS OR RESIDUAL LIQUID MEDICINE, THE STEAM TEMPERATURE WILL BE HIGH, WHICH MAY CAUSE DISCOMFORT TO CONSUMERS.