F&P NEOPUFF

Additional Manufacturer Narrative

(B)(4). METHOD: THE SUBJECT DEVICE, RD900AEU NEOPUFF INFANT RESUSCITATOR WAS RETURNED TO OUR FISHER & PAYKEL HEALTHCARE (F&P) SERVICE CENTRE IN UNITED KINGDOM, 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 INCLUDING PHOTOGRAPHY, INFORMATION PROVIDED BY THE HEALTHCARE FACILITY AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: A REVIEW OF THE SERVICE REPORT AND PHOTOGRAPHY PROVIDED BY THE F&P SERVICE TECHNICIAN HAS REVEALED THAT THE GAS INLET PORT WAS BROKEN. ADDITIONALLY, THE VALVE WAS ALSO OBSERVED TO BE FAULTY. CONCLUSION: BASED ON THE VISUAL EVALUATION OF THE PROVIDED PHOTOGRAPHY AND INFORMATION AND OUR KNOWLEDGE OF THE PRODUCT, PORT BROKEN WAS LIKELY DUE TO IMPACT DAMAGE. WE ARE UNABLE TO CONFIRM THE CAUSE OF THE FAULTY VALVE. 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 D4: UDI DETAILS ARE NOT AVAILABLE BASED ON THE TIME OF MANUFACTURING.

Description of Event or Problem

DURING DEVICE EVALUATION AND PERFORMANCE TESTING OF A RD900AEU NEOPUFF INFANT RESUSCITATOR AT OUR FISHER & PAYKEL HEALTHCARE (F&P) SERVICE CENTER IN UNITED KINGDOM, IT WAS FOUND THAT THE VALVE WAS DEFECTIVE AND GAS INLET PORT WAS BROKEN. THERE WAS NO REPORTED PATIENT INVOLVEMENT.