F&P NEOPUFF

Additional Manufacturer Narrative

(B)(6). SECTION G4: THE RD900ALU NEOPUFF INFANT RESUSCITATOR IS NOT SOLD IN THE UNITED STATES OF AMERICA (USA) BUT INSTEAD A SIMILAR PRODUCT, RD900AEU NEOPUFF INFANT RESUSCITATOR IS SOLD IN THE USA. THEREFORE, THE 510(K) NUMBER FOR RD900AEU IS K971695. 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 DISTRIBUTOR IN ITALY REPORTED ON BEHALF OF ANOTHER DISTRIBUTOR VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE GAS OUTLET PORT OF AN RD900ALU NEOPUFF INFANT RESUSCITATOR WAS BROKEN. THERE WAS NO REPORTED PATIENT CONSEQUENCES.