Additional Manufacturer Narrative · 1
RESULTS EVALS: INVESTIGATION: THE RETURNED UNIT WAS FUNCTIONALLY TESTED AND THE REPORT OF LEAKAGE WAS CONFIRMED. IT WAS NOTED THAT A PART OF THE DISTAL CUFF SKIRT HAD FAILED TO BOND SUFFICIENTLY. A HISTORIC COMPLAINTS REVIEW CONFIRMED THIS TO BE THE FIRST COMPLAINT OF THIS NATURE FOR THIS PROD CODE. WE WERE UNABLE TO REVIEW THE MFG RECORDS AS THE LOT NUMBER WAS NOT RECORDED. A FURTHER REVIEW OF MFG RECORDS CONFIRMED THE PRESENCE OF A CUFF INFLATION CHECK CARRIED OUT ON 100% OF THIS PROD LINE. ROOT CAUSE: THE ROOT CAUSE OF THIS EVENT WAS LIKELY AN INSUFFICIENT BOND AT THE TIME OF MFR. THE FOLLOWING CORRECTIVE ACTIONS WERE UNDERTAKEN FOLLOWING A SIMILAR INCIDENT OF CUFF LEAKAGE: ALL RELEVANT PERSONNEL WERE RETRAINED IN THE SUBSEQUENT CUFF INFLATION LEAK TEST. MACHINE SETTING STAFF WERE RETRAINED IN THE SET-UP OF THE CUFF WELDING MACHINE. OPERATORS WERE RETRAINED IN THE CUFF WELDING PROCESS. THOUGH WE ARE UNABLE TO CONFIRM THE DATE OF MFR, WITHOUT THE LOT DETAILS, THE ABOVE CORRECTIONS WILL ENSURE THIS TYPE OF FAILER DOES NOT RECUR. THIS REPORT HAS BEEN LOGGED FOR TRENDING.