F&P NEOPUFF

Additional Manufacturer Narrative

(B)(4). FISHER & PAYKEL HEALTHCARE (F&P) IS CURRENTLY IN THE PROCESS OF COMPLETING OUR INVESTIGATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

Description of Event or Problem

A HEALTHCARE FACILITY IN TEXAS HAS REPORTED THAT THE PRESSURE OF A RD900AEU NEOPUFF INFANT RESUSCITATOR WAS NOT GOING PAST 10-15CMH2O DURING USE. THE HEALTHCARE FACILITY FURTHER REPORTED THAT THE ISSUE COULD NOT BE REPLICATED DURING TESTING. THERE WAS NO REPORTED PATIENT CONSEQUENCE.

Description of Event or Problem

A HEALTHCARE FACILITY IN (B)(6) HAS REPORTED THAT THE PRESSURE OF A RD900AEU NEOPUFF INFANT RESUSCITATOR WAS NOT GOING PAST 10-15CMH2O DURING USE. THE HEALTHCARE FACILITY FURTHER REPORTED THAT THE ISSUE COULD NOT BE REPLICATED DURING TESTING. THERE WAS NO REPORTED PATIENT CONSEQUENCE.

Additional Manufacturer Narrative

(B)(6). METHOD: THE SUBJECT DEVICE, RD900AEU NEOPUFF INFANT RESUSCITATOR WAS RETURNED TO OUR FISHER & PAYKEL HEALTHCARE (F&P) SERVICE CENTER IN (B)(6) WHERE IT WAS INSPECTED BY A TRAINED F&P SERVICE TECHNICIAN. OUR INVESTIGATION IS THUS BASED ON THE INFORMATION PROVIDED BY THE F&P SERVICE TECHNICIAN, THE INFORMATION PROVIDED BY THE HEALTHCARE FACILITY AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: THE SUBJECT DEVICE WAS PERFORMANCE TESTED BY A F&P SERVICE TECHNICIAN. THE SUBJECT DEVICE HAS PASSED THE PERFORMANCE TESTING AND THE F&P SERVICE TECHNICIAN COULD NOT REPLICATE THE REPORTED EVENT. NO FAULT COULD BE IDENTIFIED WITH THE SUBJECT DEVICE. CONCLUSION: WE COULD NOT CONFIRM AND DETERMINE THE CAUSE OF THE REPORTED EVENT. AS PART OF OUR MANUFACTURING PROCESS, EACH NEOPUFF UNIT UNDERGOES 100% TESTING ON THE PRODUCTION LINE TO ENSURE COMPLIANCE WITH CRITICAL PRODUCT SPECIFICATIONS. UNITS THAT DO NOT MEET THE SPECIFICATIONS ARE REJECTED.