PORTEX CUFF PRESSURE MONITORING

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)(4) 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.