HUDSON POCKET PEAK FLOW METER

Description of Event or Problem

THE COMPLAINT IS REPORTED AS: THE CUSTOMER ALLEGES THAT THE POCKET PEAK FLOW METER IS GIVING AN INACCURATE READING. THE PT'S CONDITION IS REPORTED AS FINE.

Additional Manufacturer Narrative

THE SAMPLE WAS NOT AVAILABLE FOR EVAL, THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED. BASED ON SIMILAR COMPLAINTS IN THE PAST, HOWEVER, A CAPA WAS OPENED BY THE VENDOR OF THE POCKET PEAKS TO ADDRESS THE ISSUE WITH INACCURATE READINGS. THE VENDOR ALSO REPORTED THAT ADDITIONAL CHECKS WERE MADE ON THE MOLD IN LATE 2013, AND IT WAS VERIFIED THAT THE ASSEMBLY PROCESS WAS NOT CHANGED OR MODIFIED. PRIOR TO RELEASE, THE UNITS MUST MEET MFG CRITERIA AND THEY ARE 100% TESTED BEFORE LEAVING THE FACILITY. THE VENDOR ALSO REPORTS THAT IN (B)(4) 2014 THE FORMULATION OF THE POLYPROPYLENE MATERIAL USED FOR THE BLUE MEASUREMENT INDICATOR ON THE PACKET PEAKS WAS CHANGED. THE CHANGE DOES NOT AFFECT THE FIT, FORM, FUNCTION, APPEARANCE, OR SAFETY OF THE POCKET PEAKS. THE MATERIAL CHANGE WAS MADE TO IMPROVE THE CONSISTENCY OF THE BLUE MEASUREMENT INDICATOR. IF THE SAMPLE IS RETURNED, A FOLLOW-UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS.