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 SPAIN REPORTED THAT THE ADJUSTMENT BUTTONS OF AN RD900ASU NEOPUFF INFANT RESUSCITATOR ARE DAMAGED AND DOES NOT ALLOW THE AIR TO PASS THROUGH. THERE WAS NO REPORTED PATIENT CONSEQUENCE.

Additional Manufacturer Narrative

(B)(4). METHOD: THE SUBJECT DEVICE, RD900ASU NEOPUFF INFANT RESUSCITATOR WAS RETURNED TO OUR FISHER & PAYKEL HEALTHCARE (F&P) SERVICE CENTRE WHERE IT WAS PERFORMANCE TESTED 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: A REVIEW OF THE SERVICE REPORT CONFIRMED THAT THE VALVE ASSEMBLY IN THE SUBJECT DEVICE WAS DAMAGED, CONFIRMING THE REPORTED EVENT. ADDITIONALLY, THE MANOMETER IN THE SUBJECT DEVICE WAS NOT OPERATIONAL. CONCLUSION: WE ARE UNABLE TO DETERMINE THE CAUSE OF THE REPORTED EVENT. AS PART OF 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. THE SUBJECT NEOPUFF WOULD HAVE MET THE REQUIREMENTS AT THE TIME OF PRODUCTION. THE NEOPUFF CAN BE SUSCEPTIBLE TO IMPACT DAMAGE, FOR INSTANCE WHEN ACCIDENTALLY DROPPED OR SUBJECTED TO CONSIDERABLE EXTERNAL FORCE. THE NEOPUFF TECHNICAL MANUAL WARNS AGAINST DROPPING THE NEOPUFF OR SUBJECTING IT TO IMPACT DAMAGE WHICH MAY CAUSE THE UNIT TO OPERATE INCORRECTLY. IF THE NEOPUFF IS SUSPECTED TO HAVE BEEN DAMAGED, THE MANOMETER AND VALVE SYSTEM SHOULD BE PERFORMANCE TESTED. IN ADDITION, THE NEOPUFF USER INSTRUCTIONS STATE THAT THE USER SHOULD "CHECK MANOMETER READS ZERO WITH NO GAS FLOW" AND CHECK THE PRESSURE SETTINGS "PRIOR TO EVERY USE OF THE NEOPUFF". AS MENTIONED, THE NEOPUFF TECHNICAL MANUAL STATES THE FOLLOWING:- DROPPING THE NEOPUFF / PERIVENT INFANT RESUSCITATOR OR OTHER SIMILAR FORMS OF IMPACT MAY CAUSE DAMAGE RESULTING IN INCORRECT OPERATION OF THE UNIT. IF YOU SUSPECT DAMAGE TO HAVE OCCURRED, PLEASE PERFORM CHECKS AS OUTLINED [IN THE MANUAL] BEFORE CONNECTION TO A PATIENT.

Description of Event or Problem

A HEALTHCARE FACILITY IN SPAIN REPORTED THAT THE ADJUSTMENT BUTTONS OF AN RD900ASU NEOPUFF INFANT RESUSCITATOR ARE DAMAGED AND DO NOT ALLOW THE AIR TO PASS THROUGH. THERE WAS NO REPORTED PATIENT CONSEQUENCE.