AIRVO TUBE AND CHAMBER KIT WITH NEBULISER ADAPTOR
Report
- Report Number
- 9611451-2024-00780
- Event Type
- Malfunction
- Date Received
- October 29, 2024
- Date of Event
- September 26, 2024
- Report Date
- September 30, 2024
- Manufacturer
- FISHER & PAYKEL HEALTHCARE LTD
- Product Code
- CAF
- UDI-DI
- 09420012447517
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SF
- Reporter Occupation
- 003
Narratives
(B)(4). 900PT562 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 K211560. 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. METHOD: THE SUBJECT HBT AS PART OF THE 900PT562 AIRVO TUBE AND CHAMBER KIT WITH NEBULISER ADAPTOR WAS RECEIVED AT FISHER & PAYKEL HEALTHCARE (F&P) IN NEW ZEALAND FOR INVESTIGATION, WHERE IT WAS VISUALLY INSPECTED. THE CUSTOMER ALSO PROVIDED ADDITIONAL INFORMATION RELATING TO THE REPORTED EVENT UPON REQUEST. OUR INVESTIGATION IS THUS BASED ON THE EVALUATION OF THE SUBJECT HBT, THE INFORMATION PROVIDED BY THE CUSTOMER AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: THE VISUAL INSPECTION REVEALED THAT A SECTION OF THE HBT HAD MELTED AND FLATTENED IN SHAPE NEAR THE PATIENT END CONNECTOR. AS THE HBT RECEIVED HAD BEEN PULLED APART INTO TWO PIECES A RESISTENCE CHECK ON THE HEATER WIRE COULD NOT BE TESTED. THE HEALTHCARE FACILITY REPORTED THAT THEY WERE NOT AWARE IF THE HBT HAD BEEN COVERED AND THAT THE PATIENT HAD BEEN COVERED WITH ONLY A LIGHT BLANKET. CONCLUSION: WHILE WE ARE UNABLE TO CONFIRM IF THE HBT HAD BEEN COVERED, BASED ON THE NATURE OF THE DAMAGE TO THE SUBJECT HBT THE REPORTED EVENT WAS LIKELY CAUSED BY FACTORS SUCH AS INCORRECT SET-UP OR COVERING THE HBT WITH A MATERIAL OR OBJECT FOR A PROLONGED PERIOD AS INDICATED IN THE FLATTENED SHAPE OF THE RETURNED DEVICE. THE 900PT562 USER INSTRUCTIONS SHOW IN PICTORIAL FORMAT THE CORRECT PLACEMENT OF THE DEVICE AND INCLUDES THE FOLLOWING INFORMATION: - "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 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 ." - "DO NOT ALLOW THE BREATHING TUBE TO REMAIN IN DIRECT CONTACT WITH SKIN FOR PROLONGED PERIODS OF TIME." ALL HBTS AS PART OF THE 900PT562 AIRVO TUBE AND CHAMBER KIT WITH NEBULISER ADAPTOR ARE VISUALLY INSPECTED AND UNDERGO FUNCTIONAL TESTS, INCLUDING SOAK AND TEMPERATURE, AND HEATER WIRE RESISTANCE. THE HEATED BREATHING TUBES 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 HBT WOULD HAVE MET THE REQUIRED SPECIFICATIONS AT THE TIME OF PRODUCTION. THE AIRVO 2 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 900PT562 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 2 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 PATIENT END OF THE HBT IS OVER MOULDED WITH THE THERMOPLASTIC POLYMER POLYPROPYLENE, ENSURING IT IS EXCLUDED FROM THE GAS PATH. - THE AIRVO 2 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 2 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 2 DEVICE IS CONTINUOUSLY CHECKS POWER IN THE HBT AND DISABLES THE HEATER WIRE IF THE MEASURED POWER IS TOO HIGH.
(B)(6). 900PT562 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 K211560. THE SUBJECT DEVICE IS IN TRANSIT TO FISHER & PAYKEL HEALTHCARE NEW ZEALAND FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR 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 DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN SOUTH AFRICA THAT THE HEATED BREATHING TUBE AS PART OF THE 900PT562 AIRVO TUBE AND CHAMBER KIT WITH NEBULISER ADAPTOR WAS FOUND MELTED DURING USE. THERE WERE NO REPORTED PATIENT CONSEQUENCES.
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN SOUTH AFRICA THAT THE HEATED BREATHING TUBE AS PART OF THE 900PT562 AIRVO TUBE AND CHAMBER KIT WITH NEBULISER ADAPTOR WAS FOUND MELTED DURING USE. THERE WERE NO REPORTED PATIENT CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1021294 | AIRVO TUBE AND CHAMBER KIT WITH NEBULISER ADAPTOR | HEATED BREATHING TUBE | CAF | FISHER & PAYKEL HEALTHCARE LTD | 900PT562 | 2102909262 | 09420012447517 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | F&P OJR414 OPTILFOW JUNIOR 2 NASAL CANNULA MEDIUM| F&P OJR414 OPTILFOW JUNIOR 2 NASAL CANNULA MEDIUM| F&P PT101 AIRVO 2 HUMIDIFIER| F&P PT101 AIRVO 2 HUMIDIFIER |