FISHER & PAYKEL HEALTHCARE
Report
- Report Number
- 9611451-2023-00986
- Event Type
- Malfunction
- Date Received
- November 7, 2023
- Report Date
- October 11, 2023
- Manufacturer
- FISHER & PAYKEL HEALTHCARE LTD
- Product Code
- CAF
- PMA / PMN Number
- K162553
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SF
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
(B)(4). THE F&P 900PT562 AIRVO TUBE AND CHAMBER KIT WITH NEBULIZER ADAPTER IS NOT CURRENTLY AVAILABLE FOR SALE IN THE UNITED STATES OF AMERICA (USA) BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT, THE 900PT561 HEATED BREATHING TUBE AND CHAMBER KIT, IS K162553 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 NEBULIZER ADAPTER WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE (F&P) FOR EVALUATION. OUR INVESTIGATION IS BASED ON THE PHOTOGRAPHS AND DESCRIPTION OF EVENTS PROVIDED BY THE CUSTOMER, PREVIOUS INVESTIGATIONS OF SIMILAR COMPLAINTS AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: VISUAL INSPECTION OF THE PROVIDED PHOTOGRAPHS REVEALED THAT THE HBT HAD MELTED, EXPOSING THE HEATER WIRES. EVIDENCE OF BURN MARKS ON ON THE BEDDING AND PILLOW CASE WERE ALSO OBSERVED. THE CUSTOMER REPORTED THAT THE SUBJECT COMPLAINT DEVICE WAS PLACED UNDER THE PATIENTS PILLOW/BLANKET. CONCLUSION: DAMAGE TO THE HEATED BREATHING TUBE WAS CAUSED BY IT BEING COVERED BY THE PATIENTS PILLOW/BLANKET FOR A PROLONGED PERIOD. THE 900PT562 USER INSTRUCTIONS SHOW IN PICTORIAL FORMAT THE CORRECT PLACEMENT OF THE DEVICE AND INCLUDES THE FOLLOWING INFORMATION: - "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." - "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" ALL HBTS AS PART OF THE 900PT562 AIRVO TUBE AND CHAMBER KIT WITH NEBULIZER ADAPTER 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 AIRVO TUBE AND CHAMBER KIT WITH NEBULIZER ADAPTER 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)(4). UDI RELATED DATA QUALITY UPDATES ONLY. CORRECTIONS TO REFLECT GUDID: SECTION D1: BRAND NAME UPDATED TO FISHER & PAYKEL HEALTHCARE. SECTION D2A: COMMON DEVICE NAME UPDATED TO HEATED BREATHING TUBE AND CHAMBER KIT. SECTION D2B: PRODUCT CODE UPDATED TO CAF. SECTION D4: SERIAL NUMBER INTENTIONALLY LEFT BLANK AS THE INFORMATION IS NOT APPLICABLE. SECTION D4: LOT NUMBER AND UDI DETAILS WERE NOT PROVIDED BY THE HEALTHCARE FACILITY. SECTION G1: CONTACT PERSON UPDATED TO (B)(6). SECTION G4: THE F&P 900PT562 AIRVO TUBE AND CHAMBER KIT WITH NEBULIZER ADAPTER IS NOT CURRENTLY AVAILABLE FOR SALE IN THE UNITED STATES OF AMERICA (USA) BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT, THE 900PT563 HEATED BREATHING TUBE AND CHAMBER KIT, 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 NEBULIZER ADAPTER WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE (F&P) FOR EVALUATION. OUR INVESTIGATION IS BASED ON THE PHOTOGRAPHS AND DESCRIPTION OF EVENTS PROVIDED BY THE CUSTOMER, PREVIOUS INVESTIGATIONS OF SIMILAR COMPLAINTS AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: VISUAL INSPECTION OF THE PROVIDED PHOTOGRAPHS REVEALED THAT THE HBT HAD MELTED, EXPOSING THE HEATER WIRES. EVIDENCE OF BURN MARKS ON ON THE BEDDING AND PILLOW CASE WERE ALSO OBSERVED. THE CUSTOMER REPORTED THAT THE SUBJECT COMPLAINT DEVICE WAS PLACED UNDER THE PATIENTS PILLOW/BLANKET. CONCLUSION: DAMAGE TO THE HEATED BREATHING TUBE WAS CAUSED BY IT BEING COVERED BY THE PATIENTS PILLOW/BLANKET FOR A PROLONGED PERIOD. THE 900PT562 USER INSTRUCTIONS SHOW IN PICTORIAL FORMAT THE CORRECT PLACEMENT OF THE DEVICE AND INCLUDES THE FOLLOWING INFORMATION: "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." "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" ALL HBTS AS PART OF THE 900PT562 AIRVO TUBE AND CHAMBER KIT WITH NEBULIZER ADAPTER 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 AIRVO TUBE AND CHAMBER KIT WITH NEBULIZER ADAPTER 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)(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. 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 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 ADAPTER WAS FOUND MELTED DURING USE. THE HEALTHCARE FACILITY ALSO REPORTED THAT THE PT101 AIRVO 2 HUMIDIFIER TRIGGERED A CHECK FOR LEAKS ALARM, AND FOUND THE TUBE WAS KINKED UNDERNEATH THE PATIENTS PILLOW. THE TUBE WAS DISCOVERED MELTED, WITH BURN MARKS ON THE PATIENT'S PILLOW AND MATTRESS COVER. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN SOUTH AFRICA 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 ADAPTER WAS FOUND MELTED DURING USE. THE HEALTHCARE FACILITY ALSO REPORTED THAT THE PT101 AIRVO 2 HUMIDIFIER TRIGGERED A CHECK FOR LEAKS ALARM, AND FOUND THE TUBE WAS KINKED UNDERNEATH THE PATIENTS PILLOW. THE TUBE WAS DISCOVERED MELTED, WITH BURN MARKS ON THE PATIENT'S PILLOW AND MATTRESS COVER. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN SOUTH AFRICA 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 ADAPTER WAS FOUND MELTED DURING USE. THE HEALTHCARE FACILITY ALSO REPORTED THAT THE PT101 AIRVO 2 HUMIDIFIER TRIGGERED A CHECK FOR LEAKS ALARM, AND FOUND THE TUBE WAS KINKED UNDERNEATH THE PATIENTS PILLOW. THE TUBE WAS DISCOVERED MELTED, WITH BURN MARKS ON THE PATIENT'S PILLOW AND MATTRESS COVER. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 812866 | FISHER & PAYKEL HEALTHCARE | HEATED BREATHING TUBE AND CHAMBER KIT | CAF | FISHER & PAYKEL HEALTHCARE LTD | 900PT562 | NOT PROVIDED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | F&P PT101 AIRVO 2 HUMIDIFIER| F&P PT101 AIRVO 2 HUMIDIFIER| F&P PT101 AIRVO 2 HUMIDIFIER |