FISHER & PAYKEL HEALTHCARE
Report
- Report Number
- 9611451-2025-00594
- Event Type
- Malfunction
- Date Received
- June 27, 2025
- Report Date
- September 12, 2025
- Manufacturer
- FISHER & PAYKEL HEALTHCARE LTD
- Product Code
- BTT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4) SECTION D4: THE HEALTHCARE FACILITY REPORTED THAT COMPLETE DEVICE IDENTIFICATION INFORMATION WAS NOT AVAILABLE. SECTION G4: THE 950N61 NEONATAL NONINVASIVE SINGLE HEATED CIRCUIT KIT IS NOT SOLD IN THE USA, BUT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THAT PRODUCT IS THE 950N61J NEONATAL NONINVASIVE SINGLE HEATED CIRCUIT KIT. THE 510(K) FOR THAT PRODUCT IS K220703. SECTION H11: THE SUBJECT 950N61 NEONATAL NONINVASIVE SINGLE HEATED CIRCUIT KIT IS CURRENTLY EN ROUTE TO FISHER & PAYKEL (F&P) HEALTHCARE IN NEW ZEALAND FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.
(B)(4). SECTION D4: THE HEALTHCARE FACILITY REPORTED THAT COMPLETE DEVICE IDENTIFICATION INFORMATION WAS NOT AVAILABLE. SECTION G4: THE 950N61 NEONATAL NONINVASIVE SINGLE HEATED CIRCUIT KIT IS NOT SOLD IN THE USA, BUT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THE SIMILAR PRODUCT IS K220703. SECTION H11: METHOD: THE SUBJECT 950N61 NEONATAL NONINVASIVE SINGLE HEATED CIRCUIT KIT WAS RECEIVED AT FISHER & PAYKEL (F&P) HEALTHCARE IN NEW ZEALAND FOR INVESTIGATION, WHERE IT WAS VISUALLY INSPECTED AND ANALYSED. OUR INVESTIGATION IS BASED ON THE EVALUATION OF THE SUBJECT DEVICE, THE INFORMATION PROVIDED BY THE HEALTHCARE FACILITY, AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: THE HEALTHCARE FACILITY REPORTED THAT THE INSPIRATORY TUBING OF A 950N61 NEONATAL NONINVASIVE SINGLE HEATED CIRCUIT KIT WAS FOUND DAMAGED 2.5 HOURS AFTER THE PATIENT HAD BEEN DISCONNECTED, AND THAT THE DEVICE WAS COVERED BY A PILLOW WHILE THE HUMIDIFIER REMAINED TURNED ON AND GAS FLOW WAS DISCONTINUED. VISUAL INSPECTION OF THE SUBJECT DEVICE CONFIRMED THAT A LARGE SECTION OF THE INSPIRATORY TUBE HAD DELAMINATED. TUBE WAS MELTED. TESTING OF THE HEATER WIRE CONFIRMED THAT THE RESISTANCE WAS WITHIN SPECIFICATION. CONCLUSION: BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER, EVALUATION OF THE DEVICE AND OUR KNOWLEDGE OF THE PRODUCT, THE CAUSE OF THE DAMAGE TO THE INSPIRATORY TUBE OF THE 950N61 NEONATAL NONINVASIVE SINGLE HEATED CIRCUIT KIT WAS DUE TO THE TUBING BEING COVERED A PILLOW WHILE THE HUMIDIFIER REMAINED TURNED ON AND GAS FLOW WAS DISCONTINUED. THIS OCCURRED 2.5 HOURS FOLLOWING DISCONTINUATION OF PATIENT USE. ALL HEATED BREATHING TUBES (HBT) AS PART OF THE 950N61 NEONATAL NONINVASIVE SINGLE HEATED CIRCUIT KIT ARE VISUALLY INSPECTED AND UNDERGO FUNCTIONAL TESTS, INCLUDING TEMPERATURE AND HEATER WIRE RESISTANCE. THE HBT IS DESIGNED TO ENSURE THAT "UNDER NORMAL CONDITIONS" THE SURFACE TEMPERATURE DOES NOT EXCEED 44ºC AS PER ISO 80601-2-74:2021 MEDICAL ELECTRICAL EQUIPMENT: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY HUMIDIFYING EQUIPMENT. THE 950N61 NEONATAL NONINVASIVE SINGLE HEATED CIRCUIT KIT USER INSTRUCTIONS INCLUDE THE FOLLOWING TECHNICAL SPECIFICATIONS: - THE MAXIMUM TUBE TEMPERATURE IS 44ºC - OPERATING FLOW RANGE FOR THE VENTILATOR IS 1.5 - 40L/MIN. THE USER INSTRUCTIONS THAT ACCOMPANY THE 950N61 NEONATAL NONINVASIVE SINGLE HEATED CIRCUIT KIT ALSO STATES: - DO NOT CRUSH, STRETCH, OR MILK THE TUBING - DO NOT COVER THE CIRCUIT WITH MATERIALS SUCH AS TOWELS, PILLOWS, OR BED LINEN. FAILURE TO COMPLY MAY RESULT IN SKIN BURN. - SET APPROPRIATE VENTILATOR OR FLOW SOURCE ALARMS TO MONITOR THERAPY DELIVERY - APPROPRIATE PATIENT MONITORING (E.G. OXYGEN SATURATION) MUST BE USED AT ALL TIMES.
A HEALTHCARE FACILITY IN THE NETHERLANDS REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE TUBING OF A 950N61 NEONATAL NON INVASIVE SINGLE HEATED CIRCUIT KIT WAS FOUND MELTED 2.5 HOURS AFTER THE PATIENT HAD BEEN DISCONNECTED FROM THE DEVICE. THE HEALTHCARE FACILITY ALSO REPORTED THAT AFTER THE PATIENT WAS DISCONNECTED, THE 950N61 NEONATAL CIRCUIT KIT WAS COVERED BY A PILLOW WHILE THE HUMIDIFIER REMAINED TURNED ON AND GAS FLOW WAS DISCONTINUED. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
A HEALTHCARE FACILITY IN THE NETHERLANDS REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE TUBING OF A 950N61 NEONATAL NON INVASIVE SINGLE HEATED CIRCUIT KIT WAS FOUND MELTED 2.5 HOURS AFTER THE PATIENT HAD BEEN DISCONNECTED FROM THE DEVICE. THE HEALTHCARE FACILITY ALSO REPORTED THAT AFTER THE PATIENT WAS DISCONNECTED, THE 950N61 NEONATAL CIRCUIT KIT WAS COVERED BY A PILLOW WHILE THE HUMIDIFIER REMAINED TURNED ON AND GAS FLOW WAS DISCONTINUED. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1813232 | FISHER & PAYKEL HEALTHCARE | NONINVASIVE SINGLE HEATED CIRCUIT KIT | BTT | FISHER & PAYKEL HEALTHCARE LTD | 950N61 | NOT PROVIDED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | F&P HEALTHCARE 950 RESPIRATORY HUMIDIFIER| F&P HEALTHCARE 950 RESPIRATORY HUMIDIFIER| NV9 COMEN NEONATAL VENTILATOR| NV9 COMEN NEONATAL VENTILATOR| VYAIRE INFANT FLOW LP NCPAP GENERATOR| VYAIRE INFANT FLOW LP NCPAP GENERATOR |