FISHER & PAYKEL HEALTHCARE

Additional Manufacturer Narrative

(B)(4). THE SUBJECT RD900AGU NEOPUFF INFANT RESUSCITATOR WAS RETURNED TO OUR FISHER & PAYKEL HEALTHCARE (F&P) SERVICE CENTRE IN GERMANY, WHERE IT WAS INSPECTED BY A TRAINED F&P SERVICE TECHNICIAN. OUR INVESTIGATION IS BASED ON THE INFORMATION PROVIDED BY THE F&P SERVICE TECHNICIAN, INFORMATION PROVIDED BY THE HEALTHCARE FACILITY AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: PERFORMANCE TESTING OF THE SUBJECT DEVICE REVEALED THAT THE MAXIMUM P VALUE CANNOT BE SET CORRECTLY, THE VALVE WAS FOUND TO BE DEFECTIVE. CONCLUSION: WE ARE UNABLE TO CONFIRM THE CAUSE OF THE REPORTED EVENT. 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 IS A PORTABLE, REUSABLE DEVICE THAT 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. SECTION G4: THE RD900AGU NEOPUFF INFANT RESUSCITATOR IS NOT SOLD IN THE UNITED STATES OF AMERICA (USA) BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THE SIMILAR PRODUCT IS K971695.

Description of Event or Problem

DURING DEVICE EVALUATION AND PERFORMANCE TESTING OF A RD900AGU NEOPUFF INFANT RESUSCITATOR AT OUR FISHER & PAYKEL HEALTHCARE (F&P) SERVICE CENTER IN GERMANY, IT WAS FOUND THAT THE VALVE WAS DEFECTIVE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.