PORTEX CUFF PRESSURE MONITORING

Additional Manufacturer Narrative

G1,2 EMAIL IS: REGULATORY.RESPONSES@ICUMED.COM. ONE USED DECONTAMINATED DEVICE WAS RECEIVED WITH ITS ORIGINAL PACKAGING. A VIDEO WAS ALSO RECEIVED SHOWING THE CONNECTION OF CUFF INFLATOR AND A PILOT BALLOON. ONCE CONNECTED CUFF INFLATOR SHOWED PRESSURE AROUND 5CMH2O. FROM THE VIDEO IT WAS NOT POSSIBLE TO FURTHER ASSESS THE SITUATION NOR CONDITION OF CUFF INFLATOR. IT IS POSSIBLE THAT THERE COULD BE A TRACHEOSTOMY TUBE ISSUE (E.G. CUFF LEAK) THEREFORE THE POINTER SHOWED LOW PRESSURE. UNDER VISUAL INSPECTION THE RETURNED DEVICE WAS FOUND TO BE IN GOOD CONDITION, NO DEFECTS NOR DEFORMATIONS WERE FOUND. PER FUNCTIONAL TESTING, THE ACCURACY OF THE GAUGE READING WAS CHECKED. RESULTS SHOWN ON DIGITAL MANOMETER SHOULD BE WITHIN TOLERANCE +-2 CMH2O AND SHOULD MAINTAIN THIS PRESSURE FOR 10 SECONDS. BASED ON THIS TESTING THE DEVICE WAS FOUND TO BE CONFORMING - NO NONCONFORMITY WAS OBSERVED. THE COMPLAINT WAS NOT CONFIRMED. A DEVICE HISTORY RECORD (DHR) REVIEW REPORTED NO DISCREPANCIES OR NON-CONFORMANCES DURING THE MANUFACTURING OF THE REPORTED LOT NUMBER. NO ACTION WAS TAKEN SINCE THE COMPLAINT COULD NOT BE CONFIRMED.

Description of Event or Problem

IT WAS REPORTED THAT THE PRODUCT WAS DEFECTIVE. IT WAS DIAGNOSED THAT THE CUFF WAS DEFLATED. WHEN TESTING AND COMPARING IT WITH ANOTHER "CUFOMETER", THEY FOUND FAILURES IN THE MEASUREMENTS. THERE WAS A PATIENT INVOLVED. IT HAS BEEN REPORTED THERE WAS NO HARM OR INJURY, THE PATIENT ONLY RECEIVED HOME CARE FROM THE THERAPIST, WHO MEASURED THE "CUFOMETER" AND FOUND THE MEASUREMENT FAILURE. HE INFORMED THAT THE EVENT OCCURRED IN THE PATIENT'S HOME. REPORTED INFORMED THAT THEY CAN SEE THAT THE CUFF WAS AT A PRESSURE OF 30 CMH2O AND THE "CUFOMETRO" REPORTED THAT IT DID NOT REACH 10 CMH2O. THE CUSTOMER ALSO INFORMED THAT THE PATIENT HAS SEVERE DYSPHAGIA, WHERE THEY RETAIN A TRACHEOSTOMY WITH CUFF AND GTT. "AIMING TO BE A BABY WITH AN INTENSE TEMPERAMENT, WHICH MAKES THE CUFF DEFLATE FASTER, THEREFORE, THERE IS A NEED FOR 03 MEASUREMENTS PER DAY." A1: ONE PATIENT, THREE PRODUCT MALFUNCTIONS. (B)(6), (B)(6) AND (B)(6) ALL REPRESENT THE SAME PATIENT.

Additional Manufacturer Narrative

D4: UDI SECTION AND G5: 510K ARE UNKNOWN, NO INFORMATION HAS BEEN PROVIDED TO DATE. NO PRODUCT SAMPLE WAS RECEIVED; THEREFORE, VISUAL AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWS THERE WERE NO OBSERVATIONS OR NONCONFORMITIES RECORDED DURING MANUFACTURE TO SUGGEST AN ISSUE OF THIS NATURE WOULD OCCUR WITH THIS LOT OF PRODUCTS. THE REPORTED ISSUE COULD NOT BE CONFIRMED. VIDEO OF THE FAILURE WAS SUBMITTED FOR INVESTIGATION. THE VIDEO SHOWS CONNECTION OF THE CUFF INFLATOR AND A PILOT BALLOON. ONCE CONNECTED THE CUFF INFLATOR SHOWED PRESSURE AROUND 5CMH2O. FROM THE VIDEO IT IS NOT POSSIBLE TO FURTHER ASSESS THE SITUATION NOR THE CONDITION OF CUFF INFLATOR. ROOT CAUSE OF THIS INCIDENT REMAINS UNKNOWN AS WE ARE UNABLE TO FURTHER INVESTIGATE WITHOUT THE SAMPLE OR MORE INFORMATION. IF THE PRODUCT IS RETURNED, THE MANUFACTURER WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION.