F&P FLEXITRUNK

Additional Manufacturer Narrative

(B)(6). 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 G4: PMA/510(K) NUMBER - NO 510(K) NUMBER INCLUDED DUE TO THE SUBJECT DEVICE BEING EXEMPT FROM PMS PATHWAY TO REGULATORY APPROVAL.

Description of Event or Problem

A HEALTHCARE FACILITY IN CALIFORNIA REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT THE TUBING OF SIX BC191-05 FLEXITRUNK NASAL TUBING WERE FAILING DUE TO PINHOLE LEAKS OR TEARS. THERE WAS NO REPORTED PATIENT CONSEQUENCE.