FISHER & PAYKEL HEALTHCARE

Additional Manufacturer Narrative

(B)(6). D2, G4: 900PT562 IS NOT SOLD IN THE USA, BUT IT IS SIMILAR TO 900PT563 WHICH IS SOLD IN THE USA. THE 510(K) FOR THE SIMILAR PRODUCT IS K211560. D4, H4: FISHER & PAYKEL HEALTHCARE (F&P) HAVE REQUESTED FOR COMPLETE DEVICE IDENTIFICATION INFORMATION. FISHER & PAYKEL HEALTHCARE (F&P) IS CURRENTLY IN THE PROCESS OF COMPLETING F&P'S INVESTIGATION. F&P WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF F&P'S INVESTIGATION. PRODUCT BACKGROUND: THE HEATED BREATHING TUBE (HBT) IS A COMPONENT DESIGNED FOR USE WITH THE AIRVO HUMIDIFICATION SERIES, FOR THE DELIVERY OF HUMIDIFIED RESPIRATORY GASES TO PATIENTS, INCLUDING THOSE WHO ARE RECEIVING NASAL HIGH FLOW (NHF) THERAPY. NHF THERAPY IS INTENDED FOR USE WITH SPONTANEOUSLY BREATHING PATIENTS WHO WOULD BENEFIT FROM RECEIVING HIGH FLOW WARMED AND HUMIDIFIED RESPIRATORY GASES. THE AIRVO DEVICE SHOULD NOT BE USED FOR LIFE SUPPORT PURPOSES, AND APPROPRIATE PATIENT MONITORING MUST BE USED AT ALL TIMES. THE HBT AS PART OF THE AIRVO SYSTEM CONTAINS A HEATER WIRE ENCAPSULATED IN PLASTIC WHICH ENSURES OPTIMAL TEMPERATURE AND HUMIDIFICATION LEVELS ARE DELIVERED TO THE PATIENT INTERFACE WHILE MINIMIZING THE AMOUNT OF CONDENSATE IN THE TUBE.

Description of Event or Problem

A HEALTHCARE FACILITY IN IRELAND REPORTED VIA A FISHER AND PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE HEATED BREATHING TUBE AS PART OF THE 900PT562 AIRVO TUBE AND CHAMBER KIT WITH NEBULISER ADAPTOR WAS FOUND MELTED DURING USE. THE HEALTHCARE FACILITY FURTHER STATED THAT THE SUBJECT HBT WAS COVERED. THERE WAS NO PATIENT CONSEQUENCE.