F&P NEOPUFF

Additional Manufacturer Narrative

(B)(6). METHOD: THE SUBJECT DEVICE RD900AEU NEOPUFF INFANT RESUSCITATOR WAS RECEIVED AT OUR FISHER & PAYKEL HEALTHCARE (F&P) SERVICE CENTRE IN INDIA WHERE IT WAS VISUALLY INSPECTED AND SERVICED BY A TRAINED F&P SERVICE TECHNICIAN. OUR INVESTIGATION IS THUS BASED ON THE INFORMATION PROVIDED BY THE F&P SERVICE TECHNICIAN, AND OUR KNOWLEDGE OF THE PRODUCT. RESULT: UPON EVALUATION OF THE SERVICE REPORT, IT WAS OBSERVED THAT THE MANOMETER NUT WAS LOOSE. CONCLUSION: WE ARE UNABLE TO DETERMINE THE CAUSE OF THE REPORTED FAULT. 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

DURING DEVICE EVALUATION OF THE SUBJECT DEVICE, RD900AEU NEOPUFF INFANT RESUSCITATOR AT FISHER & PAYKEL HEALTHCARE (F&P) SERVICE CENTRE IN INDIA, IT WAS FOUND THAT THE MANOMETER NUT HAS BECOME LOOSE AND CAME OFF. THERE WAS NO REPORTED PATIENT INVOLVEMENT.