CIRCUIT, ADULT SINGLE-LIMB, HEATED

Additional Manufacturer Narrative

FOUR OPENED SAMPLES OF PART NUMBER AH 202 WERE RECEIVED AND A FAILURE INVESTIGATION WAS PERFORMED. THE TEMP PORTS OF THE COMPONENTS PART NUMBER 65-10139 WERE INSPECTED PER DRAWING 65-10139 AND WERE FOUND TO BE WITHIN SPECIFICATION. THE REPORTED ISSUE COULD NOT BE DUPLICATED SO NO ROOT CAUSE COULD BE DETERMINED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THEN A SUPPLEMENTAL REPORT WILL BE FILED. VYAIRE WILL CONTINUE TO TRACK AND TREND ANY RELATED ISSUES.

Additional Manufacturer Narrative

INITIAL EMDR SUBMISSION: SAMPLE IS AVAILABLE, UPS SHIPPING LABELS PROVIDED TO CUSTOMER TO HAVE THE SAMPLE RETURNED. CURRENTLY AWAITING FOR THE SAMPLE. ONCE THE INVESTIGATION IS COMPLETE A FOLLOW UP SUBMISSION WILL BE FILED.

Description of Event or Problem

CUSTOMER REPORTS THAT THE TEMPERATURE PROBE BECOMES DISLODGED FROM THE CIRCUIT AT THE HUMIDIFICATION CHAMBER WHEN USING WITH HIGH FLOW NASAL CANNULA. TODAY OUR DAY SHIFT SUPERVISOR REPORTED TO ME THAT WE HAVE HAD SEVERAL RAPID RESPONSES CALLED FOR HYPOXIA DUE TO THE TEMPERATURE PROBE BEING DISLODGED DOWN AND THE HEATER POT. OUR PREVIOUS CIRCUIT HAD A CLIP TO KEEP THIS IN PLACE, CAN THE MANUFACTURER CORRECT THIS WITH. ON 12/4/2017-ADDITIONAL INFORMATION: PRODUCT SAMPLE IS AVAILABLE. CLINICIAN WAS MADE AWARE OF THE ISSUE BECAUSE SATURATIONS DROPPED. NO MEDICAL INTERVENTION REQUIRED OTHER THAN CORRECTING THE ISSUE. DETAILS OF THE "RAPID RESPONSES" DESCRIBED BY CUSTOMER AS: "PATIENTS OXYGEN SATURATIONS DROPPED, NURSING COULD NOT FIND THE ISSUE AND RAPID RESPONSE CALLED". ON 08DEC2017-ADDITIONAL INFORMATION FROM CUSTOMER: YES THIS PRODUCT HAS NOT CHANGED SINCE WE BEGAN USING THEM, CLINICIANS WE AWARE WHEN THE PATIENTS PULSE OXIMETER ALARM WENT OFF, A RRT WAS CALLED BUT DEVICES WERE CORRECTED, PREVIOUS CIRCUIT HAD A CLIP.