Additional Manufacturer Narrative · 1
RESULTS EVALUATIONS (OTHER): INVESTIGATION: THE RETURNED UNIT WAS FUNCTIONALLY TESTED AND THE REPORT OF LEAKAGE WAS CONFIRMED. ONLY LEAKAGE TESTING WAS PERFORMED AS THE PT HAS HEPATITIS C. A REVIEW OF OUR COMPLAINTS HISTORY CONFIRMED THIS TO BE THE FIRST COMPLAINT FOR TWO POSSIBLE LOT #S IDENTIFIED. THOUGH, THERE HAVE BEEN COMPLAINTS FOR CUFF DEFLATION IN USE, ON THIS PROD CODE DURING THE PAST FIVE YRS, THESE ARE HISTORICAL AND DO NOT INDICATE A SYSTEMATIC FAILURE DURING MFR, ESPECIALLY WHEN COMPARED WITH THE VOLUME OF ANNUAL SALES. A FURTHER REVIEW OF MFG RECORDS CONFIRMED THE PRESENCE OF AN INFLATION CHECK CARRIED OUT ON 100% OF THIS PROD LINE. ROOT CAUSE: IT IS STATED THAT THE PROD WAS TESTED PRIOR TO USE AND ONLY BECAME DEFLATED TWO DAYS FOLLOWING INSERTION. AS SUCH, THIS INCIDENT IS UNLIKELY THE RESULT OF AN ASSEMBLY FAULT. WE FEEL THE MOST LIKELY CAUSE FOR THIS INCIDENT IS THAT THE CUFF BECAME DAMAGED FOLLOWING INFLATION OF THE PROD CUFF, RESULTING IN THE CUFF DEFLATION. THOUGH THESE PRODS ARE DESIGNED TO BE AS ROBUST AS FUNCTIONALLY POSSIBLE, DEFLATION OF THE PROD CUFF ON THE PT ANATOMY CAN BE EXPERIENCED. THIS REPORT HAS BEEN LOGGED FOR TRENDING.