RESUS NEO MANOMETER AND MASK

Description of Event or Problem

IT WAS REPORTED THAT PRIOR TO USE, "WE HAVE ALREADY HAD PROBLEMS WITH OUR MANUAL RESPIRATORS (AMBU BAG) THREE TIMES. THESE ARE NOT S UFFICIENTLY FILLED WITH AIR AT THE MASK, SO THAT THE PLASTIC RING UNDERNEATH CAN BE FELT QUITE DISTINCTLY WHEN PUT ON. SUFFICIENT VENTILATION OF PATIENTS IN EMERGENCY SITUATIONS NOT POSSIBLE BECAUSE MASK DOES NOT SEAL TIGHTLY WITH FACE". ADDITIONAL INFORMATION RECEIVED STATES THAT THE DEFECT WAS NOTICED "IMMEDIATELY BEFORE USE". THE PATIENT STATUS IS REPORTED AS "WELL AND DISCHARGED". A NEW DEVICE WAS USED.

Additional Manufacturer Narrative

(B)(4). THE SAMPLE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE MANUFACTURER REPORTED: "THE INSPECTION RECORD OF THE XTF0001, LOT 220822 AND MASK(S05-00004) WAS CHECKED, AND NO ABNORMALITIES WERE RECORDED. WE RECEIVED A RETURNED SAMPLE AND CONDUCTED CUSHION IMMERSION LEAKAGE TEST (WHEN THE MASK IS IMMERSED IN WATER, APPLY A FORCE OF ABOUT 8 POUNDS FOR MORE THAN 3 SECONDS), WITH NO BUBBLES (INDICATING LEAKAGE POINTS) WERE OBSERVED. ALL MASK CUSHIONS ARE SUBJECT TO 100% LEAKAGE TEST AND APPEARANCE INSPECTION DURING THE PRODUCTION PROCESS AND CAN ONLY BE PACKAGED AND SHIPPED AFTER PASSING THE TEST. REFERRING TO THE BELOW STEPS, SUFFICIENT AIR INFLATION IS GUARANTEED AT STEP1 MOLDING. AND EACH AIR CUSHION MUST BE CONDUCTED AIR LEAKAGE TEST THAT IS IMMERSING THE AIR CUSHION IN WATER FOR 4 SECONDS AT STEP 3 TO MAKE SURE ITS INTACTNESS BEFORE ASSEMBLING. SO, IT COULD BE CONFIRMED THAT WHEN EX-FACTORY RELEASING ALL AIR CUSHION MASKS WERE IN A GOOD STATE. IT HAS BEEN NEARLY TWO AND A HALF YEARS SINCE THE CUSTOMER PURCHASED THIS MASK, WHICH ALSO MEANS THE PRODUCT HAS BEEN IN STORAGE FOR A LONG TIME AND THE PRODUCT'S SHELF LIFE IS 3 YEARS. CONSIDERING THAT THE MATERIAL OF THE RETURNED SAMPLES IS PVC, ALTHOUGH THE MASK UNDERWENT 100% LEAKAGE TEST DURING THE MANUFACTURING PROCESS, THERE ARE FACTORS OUTSIDE OF THE MANUFACTURING PROCESS THAT CAN ACCELERATE PRODUCT AGING AND AFFECT ITS AIR VOLUME. THESE FACTORS INCLUDE THE STORAGE ENVIRONMENT (SUCH AS TEMPERATURE AND HUMIDITY CONDITIONS, STACKING METHODS, HANDLING, ETC.). BASED ON THE ABOVE ANALYSIS, IT IS POSSIBLE THAT EXTERNAL ENVIRONMENTAL FACTORS HAVE ACCELERATED THE AGING OF THE PRODUCT, LEADING TO AIR MOLECULES GRADUALLY ESCAPING THROUGH THE AIR CUSHION OF THE MASKS. GALEMED WILL CONVEY THE CUSTOMER FEEDBACK REGARDING THE ABNORMALITY TO THE ON-SITE STAFF, AND REQUEST THAT THEY PAY ATTENTION TO THIS PHENOMENON IN SUBSEQUENT PRODUCTION. WE ARE COMMITTED TO CONTINUOUS IMPROVEMENT AND WILL CLOSELY MONITOR ANY SIMILAR CONCERNS MOVING FORWARD." TELEFLEX WILL CONTINUE TO MONITOR AND TREND ON COMPLAINTS OF THIS NATURE. OTHER REMARKS: N/A. CORRECTED DATA: N/A.

Additional Manufacturer Narrative

(B)(4).

Description of Event or Problem

IT WAS REPORTED THAT PRIOR TO USE, "WE HAVE ALREADY HAD PROBLEMS WITH OUR MANUAL RESPIRATORS (AMBU BAG) THREE TIMES. THESE ARE NOT SUFFICIENTLY FILLED WITH AIR AT THE MASK, SO THAT THE PLASTIC RING UNDERNEATH CAN BE FELT QUITE DISTINCTLY WHEN PUT ON. SUFFICIENT VENTILATION OF PATIENTS IN EMERGENCY SITUATIONS NOT POSSIBLE BECAUSE MASK DOES NOT SEAL TIGHTLY WITH FACE". ADDITIONAL INFORMATION RECEIVED STATES THAT THE DEFECT WAS NOTICED "IMMEDIATELY BEFORE USE". THE PATIENT STATUS IS REPORTED AS "WELL AND DISCHARGED". A NEW DEVICE WAS USED.

Additional Manufacturer Narrative

(B)(4). THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THE MANUFACTURER REPORTED: "THE INSPECTION RECORD OF THE XTF0001, LOT 220822 AND MASK WAS CHECKED, AND NO ABNORMALITIES WERE RECORDED. ALL MASK CUSHIONS ARE SUBJECT TO 100% LEAKAGE TEST AND APPEARANCE INSPECTION DURING THE PRODUCTION PROCESS AND CAN ONLY BE PACKAGED AND SHIPPED AFTER PASSING THE TEST. REFERRING TO THE BELOW STEPS, SUFFICIENT AIR INFLATION IS GUARANTEED AT STEP1 MOLDING. AND EACH AIR CUSHION MUST BE CONDUCTED AIR LEAKAGE TEST THAT IS IMMERSING THE AIR CUSHION IN WATER FOR 4 SECONDS AT STEP 3 TO MAKE SURE ITS INTACTNESS BEFORE ASSEMBLING. SO, IT COULD BE CONFIRMED THAT WHEN EX-FACTORY RELEASING ALL AIR CUSHION MASKS WERE IN A GOOD STATE. T HAS BEEN NEARLY TWO AND A HALF YEARS SINCE THE CUSTOMER PURCHASED THIS MASK, WHICH ALSO MEANS THE PRODUCT HAS BEEN IN STORAGE FOR A LONG TIME AND THE PRODUCT'S SHELF LIFE IS 3 YEARS. CONSIDERING THAT THE MATERIAL OF THE RETURNED SAMPLES IS PVC, ALTHOUGH THE MASK UNDERWENT 100% LEAKAGE TESTING DURING THE MANUFACTURING PROCESS, THERE ARE FACTORS OUTSIDE OF THE MANUFACTURING PROCESS THAT CAN ACCELERATE PRODUCT AGING AND AFFECT ITS AIR VOLUME. THESE FACTORS I NCLUDE THE STORAGE ENVIRONMENT (SUCH AS TEMPERATURE AND HUMIDITY CONDITIONS, STACKING METHODS, HANDLING, ETC.). BASED ON THE ABOVE ANALYSIS, IT IS POSSIBLE THAT EXTERNAL ENVIRONMENTAL FACTORS HAVE ACCELERATED THE AGING OF THE PRODUCT, LEADING TO AIR MOLECULES GRADUALLY ESCAPING THROUGH THE AIR CUSHION OF THE MASKS. GALEMED WILL CONVEY THE CUSTOMER FEEDBACK REGARDING THE ABNORMALITY TO THE ON-SITE STAFF, AND REQUEST THAT THEY PAY ATTENTION TO THIS PHENOMENON IN SUBSEQUENT PRODUCTION. WE ARE COMMITTED TO CONTINUOUS IMPROVEMENT AND WILL CLOSELY MONITOR ANY SIMILAR CONCERNS MOVING FORWARD." TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE. OTHER REMARKS: N/A. CORRECTED DATA: N/A.

Description of Event or Problem

IT WAS REPORTED THAT PRIOR TO USE, "WE HAVE ALREADY HAD PROBLEMS WITH OUR MANUAL RESPIRATORS (AMBU BAG) THREE TIMES. THESE ARE NOT S UFFICIENTLY FILLED WITH AIR AT THE MASK, SO THAT THE PLASTIC RING UNDERNEATH CAN BE FELT QUITE DISTINCTLY WHEN PUT ON. SUFFICIENT VENTILATION OF PATIENTS IN EMERGENCY SITUATIONS NOT POSSIBLE BECAUSE MASK DOES NOT SEAL TIGHTLY WITH FACE". ADDITIONAL INFORMATION RECEIVED STATES THAT THE DEFECT WAS NOTICED "IMMEDIATELY BEFORE USE". THE PATIENT STATUS IS REPORTED AS "WELL AND DISCHARGED". A NEW DEVICE WAS USED.