F&P NEOPUFF

Additional Manufacturer Narrative

(B)(4). 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. SECTION D4 & H4: DEVICE DETAILS WERE NOT RECEIVED FROM THE CUSTOMER. SECTION G4: THE RD900AZU 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.

Description of Event or Problem

A HEALTHCARE FACILITY IN SPAIN REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE RD900ASU NEOPUFF INFANT RESUSCITATOR'S PRESSURE WAS FLUCTUATING. THERE WAS NO REPORTED PATIENT CONSEQUENCE.