FISHER & PAYKEL HEALTHCARE

Description of Event or Problem

A HEALTHCARE FACILITY IN NETHERLANDS REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT A RD900ANU NEOPUFF INFANT RESUSCITATOR HAD BEEN DROPPED. IT WAS FURTHER REPORTED THAT, FOLLOWING THE IMPACT, THE MANOMETER NEEDLE BECAME STUCK. THERE WAS NO REPORTED PATIENT CONSEQUENCE.

Additional Manufacturer Narrative

(B)(4). SECTION G4: THE RD900ANU IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THE SIMILAR PRODUCT IS K971695. METHOD: THE SUBJECT DEVICE RD900ANU NEOPUFF INFANT RESUSCITATOR WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE (F&P) FOR EVALUATION. OUR INVESTIGATION IS BASED ON THE INFORMATION PROVIDED BY THE HEALTHCARE FACILITY AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: THE HEALTHCARE FACILITY REPORTED THAT THE SUBJECT DEVICE HAD BEEN DROPPED. IT WAS FURTHER REPORTED THAT, FOLLOWING THE IMPACT, THE MANOMETER NEEDLE BECAME STUCK. CONCLUSION: BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER, THE REPORTED EVENT RESULTED FROM IMPACT DAMAGE. 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".