FISHER & PAYKEL HEALTHCARE
Report
- Report Number
- 9611451-2025-00981
- Event Type
- Malfunction
- Date Received
- October 1, 2025
- Date of Event
- September 1, 2025
- Report Date
- November 26, 2025
- Manufacturer
- FISHER & PAYKEL HEALTHCARE LTD
- Product Code
- CAF
- PMA / PMN Number
- K211560
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
(B)(4). D4, H4: COMPLETE DEVICE IDENTIFICATION INFORMATION WAS REQUESTED BUT NOT PROVIDED BY THE HEALTHCARE FACILITY. 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 MINIMISING THE AMOUNT OF CONDENSATE IN THE TUBE. METHOD: THE SUBJECT HBT AS PART OF THE 900PT563 AIRVO TUBE AND CHAMBER KIT WITH NEBULISER ADAPTOR WAS RECEIVED AT FISHER & PAYKEL HEALTHCARE (F&P) NEW ZEALAND WHERE IT WAS VISUALLY INSPECTED AND RESISTANCE TESTED. F&P'S INVESTIGATION IS BASED ON THE EVALUATION OF THE SUBJECT HBT, INFORMATION AND PHOTOGRAPHY PROVIDED BY THE HEALTHCARE FACILITY, PREVIOUS INVESTIGATIONS OF SIMILAR COMPLAINTS, AND F&P'S KNOWLEDGE OF THE PRODUCT. RESULTS: VISUAL INSPECTION OF THE SUBJECT HBT CONFIRMED THAT THE SUBJECT HBT WAS COMPRESSED AND MELTED IN THE MIDSECTION OF THE TUBING. THE PHOTOGRAPHY PROVIDED BY THE HEALTHCARE FACILITY REVEALED PLASTIC RESIDUE FROM THE SUBJECT HBT EMBEDDED IN THE PATIENT'S BEDDING. THE HEALTHCARE FACILITY STATED THAT THE PATIENT WAS ON THE DEVICE DURING THE REPORTED EVENT, HOWEVER, DID NOT CONFIRM WHETHER THE SUBJECT HBT HAD BEEN COVERED. F&P MADE MULTIPLE REQUESTS FOR FURTHER INFORMATION REGARDING THE REPORTED EVENT, HOWEVER, NO FURTHER INFORMATION WAS PROVIDED BY THE HEALTHCARE FACILITY. THERE WERE NO PATIENT CONSEQUENCES REPORTED BY THE HEALTHCARE FACILITY. CONCLUSION: F&P'S INVESTIGATION WAS UNABLE TO DETERMINE THE EXACT CAUSE OF THE REPORTED EVENT. BASED ON F&P'S KNOWLEDGE OF THE PRODUCT, PREVIOUS INVESTIGATIONS OF SIMILAR COMPLAINTS, AND THE PHOTOGRAPHY AND INFORMATION PROVIDED BY THE HEALTHCARE FACILITY, THE DAMAGE TO THE SUBJECT HBT AS PART OF THE 900PT563 AIRVO TUBE AND CHAMBER KIT WITH NEBULISER ADAPTOR WAS LIKELY CAUSED BY THE SUBJECT HBT BEING COVERED FOR A PROLONGED PERIOD. THE PHOTOGRAPHY PROVIDED BY THE HEALTHCARE FACILITY REVEALED PLASTIC RESIDUE FROM THE SUBJECT HBT EMBEDDED IN THE PATIENT'S BEDDING. THE 900PT563 USER INSTRUCTIONS SHOW IN PICTORIAL FORMAT THE CORRECT PLACEMENT OF THE DEVICE AND INCLUDES THE FOLLOWING INFORMATION: "DO NOT ADD HEAT TO ANY PART OF THE BREATHING TUBE E.G., COVERING WITH A BLANKET, OR HEATING IT IN AN INCUBATOR OR OVERHEAD HEATER FOR A NEONATE, AS THIS COULD RESULT IN SERIOUS INJURY." "CONNECT BREATHING TUBE CLIP TO PATIENT CLOTHING OR BEDDING." "NEVER OPERATE THE UNIT IF THE BREATHING TUBE HAS BEEN DAMAGED WITH HOLES, TEARS OR KINKS" "DO NOT BLOCK THE FLOW OF AIR THROUGH THE UNIT AND BREATHING TUBE." "DO NOT ALLOW THE BREATHING TUBE TO REMAIN IN DIRECT CONTACT WITH SKIN FOR PROLONGED PERIODS OF TIME." ALL HBTS AS PART OF THE 900PT563 ARE VISUALLY INSPECTED AND UNDERGO FUNCTIONAL TESTS, INCLUDING SOAK AND TEMPERATURE, AND HEATER WIRE RESISTANCE. THE HBTS ARE 100% VISUALLY INSPECTED USING A CAMERA SYSTEM. THE HBTS ARE ALSO TESTED FOR RESISTANCE, CONTINUITY, POLARITY AND PITCH DURING PRODUCTION. ADDITIONALLY, A FUNCTIONAL TEST IS CONDUCTED UNDER LOAD. THE SUBJECT HBT WOULD HAVE MET THE REQUIRED SPECIFICATIONS AT THE TIME OF PRODUCTION. THE AIRVO SYSTEM IS DESIGNED TO COMPLY WITH THE ELECTRICAL SAFETY STANDARD IEC 60601-1: 2005+A1:2012. THE CASE IS COMPOSED OF A FLAME RETARDANT MATERIAL. THE SURFACE TEMPERATURE OF THE HBT, WHEN USED IN ACCORDANCE WITH USER INSTRUCTIONS, IS DESIGNED TO BE WITHIN THE LIMITS SPECIFIED BY ISO 8185 WITH REGARD TO HOT TUBE SURFACE TEMPERATURE NOT EXCEEDING 44° CELSIUS. IT IS AN INHERENT RISK OF HBTS, THAT ADDITIONAL HEAT (ABOVE AMBIENT LEVELS) ADDED TO ANY PART OF THE TUBE VIA AN EXTERNAL SOURCE OR BEING COVERED WITH MATERIAL, MAY LEAD TO THE TUBING BECOMING DAMAGED. TO ADDRESS THIS INHERENT RISK AND AS IS REQUIRED UNDER ISO 80601, THE USER INSTRUCTIONS FOR THE 900PT563 CONTAINS THE WARNING "DO NOT ADD HEAT TO ANY PART OF THE BREATHING TUBE E.G. COVERING WITH A BLANKET, OR HEATING IT IN AN INCUBATOR OR OVERHEAD HEATER FOR A NEONATE, AS THIS COULD RESULT IN SERIOUS INJURY." ADDITIONAL "DO NOT COVER" TAGS ARE ALSO ATTACHED TO ALL HBTS TO ALERT THE USER THAT THE HBT SHOULD NOT BE COVERED. THERE ARE MANY SAFETY FEATURES INCORPORATED INTO THE AIRVO SYSTEM TO PREVENT OVERHEATING AND FIRE. THESE INCLUDE: THE HEATER WIRES IN THE HBT ARE COMPLETELY INSULATED FROM THE GAS PATH. THE PCB AT THE USER END OF THE HBT IS OVER MOULDED WITH THE THERMOPLASTIC POLYMER POLYPROPYLENE, ENSURING IT IS EXCLUDED FROM THE GAS PATH. THE AIRVO DEVICE CONTAINS TECHNOLOGY WHICH DETECTS SHORT CIRCUITS AND TRANSIENT CURRENT EVENTS IN THE HBT. WHEN DETECTED, THE AIRVO REMOVES POWER TO THE HBT. THE AIRVO PERFORMS THIS DETECTION AT ANY TIME IT IS TURNED ON AND CONNECTED TO THE HBT. THIS FUNCTIONALITY IS CHECKED BY THE CONTROL SYSTEM EACH TIME THE AIRVO IS POWERED UP, OR WHEN A NEW HBT IS CONNECTED. AN 'OVER-TEMPERATURE' SENSOR WILL AUTOMATICALLY CUT POWER TO THE MOTOR, HEATER PLATE AND HEATER WIRE IF IT DETECTS ANY OVERHEATING AT THE CHAMBER OR THE PATIENT END OF THE HBT. THE AIRVO DEVICE CONTINUOUSLY CHECKS POWER IN THE HBT AND DISABLES THE HEATER WIRE IF THE MEASURED POWER IS TOO HIGH.
(B)(4). [D4: FISHER & PAYKEL HEALTHCARE (F&P) HAS REQUESTED FOR THE COMPLAINT DEVICE DETAILS.] 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 2 HUMIDIFIER (AIRVO 2), 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 2 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 2 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.
A HEALTHCARE FACILITY IN NORTH CAROLINA REPORTED VIA A FISHER AND PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE HEATED BREATHING TUBE AS PART OF THE 900PT563 AIRVO TUBE AND CHAMBER KIT WITH NEBULISER ADAPTOR WAS FOUND MELTED DURING USE. THERE WAS NO PATIENT CONSEQUENCE.
A HEALTHCARE FACILITY IN NORTH CAROLINA REPORTED VIA A FISHER AND PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE HEATED BREATHING TUBE AS PART OF THE 900PT563 AIRVO TUBE AND CHAMBER KIT WITH NEBULISER ADAPTOR WAS FOUND MELTED DURING USE. THERE WAS NO PATIENT CONSEQUENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2426624 | FISHER & PAYKEL HEALTHCARE | HEATED BREATHING TUBE | CAF | FISHER & PAYKEL HEALTHCARE LTD | 900PT563 | 2101798020 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | F&P PT101 AIRVO 2 HUMIDIFIER |