FISHER & PAYKEL HEALTHCARE
Report
- Report Number
- 9611451-2025-01622
- Event Type
- Malfunction
- Date Received
- November 20, 2025
- Report Date
- December 3, 2025
- Manufacturer
- FISHER & PAYKEL HEALTHCARE LTD
- Product Code
- BTT
- UDI-DI
- 09420012450029
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
(B)(4). SECTION D4: DEVICE INDENTIFICATION DETAILS WERE NOT RECEIVED. SECTION G4: THE 950N81 NEONATAL VENTILATOR DUAL 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 THAT PRODUCT IS K220703. METHOD: THE SUBJECT 950N81 NEONATAL VENTILATOR DUAL HEATED CIRCUIT KIT WAS NOT RETURNED TO FISHER & PAYKEL (F&P) HEALTHCARE FOR INVESTIGATION. OUR INVESTIGATION IS THUS BASED ON THE INFORMATION PROVIDED BY THE HEALTHCARE FACILITY AND KNOWLEDGE ABOUT THE PRODUCT. RESULTS: THE CUSTOMER REPORTED EXPERIENCING DIFFICULTY WHEN ATTEMPTING TO INSERT THE PRESSURE LINE INTO THE EXPIRATORY LIMB, NOTING THAT THE CONNECTION WAS NOT SECURE, AND THE LINE WOULD DETACH. CONCLUSION: IT WAS REPORTED THAT THE HEALTHCARE FACILITY STAFF WERE RETRAINED ON HOW TO INSERT THE PRESSURE LINE CORRECTLY AND THE DEVICE WAS PERFORMING AS INTENDED. THE USER INSTRUCTIONS FOR THE 950N81 NEONATAL VENTILATOR DUAL HEATED CIRCUIT KIT STATE THE FOLLOWING: SET APPROPRIATE VENTILATOR OR FLOW SOURCE ALARMS TO MONITOR THERAPY DELIVERY. PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM BEFORE CONNECTING TO A PATIENT. CHECK ALL CONNECTIONS ARE TIGHT BEFORE USE.
(B)(4). SECTION D4: DEVICE INDENTIFICATION DETAILS WERE NOT RECEIVED. SECTION G4: THE 950N81 NEONATAL VENTILATOR DUAL 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 THAT PRODUCT IS K220703. THE SUBJECT 950N81 NEONATAL VENTILATOR DUAL HEATED CIRCUIT KIT HAS BEEN REQUESTED TO BE RETURNED TO FISHER & PAYKEL HEALTHCARE NEW ZEALAND FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.
A HEALTHCARE FACILITY IN SWEDEN REPORTED VIA A FISHER AND PAYKEL (F&P) HEALTHCARE FIELD REPRESENTATIVE THAT THE CONNECTION OF THE 950N81 NEONATAL VENTILATOR DUAL HEATED CIRCUIT KIT TO THE PRESSURE LINE WOULD DETACH. THERE WAS NO PATIENT INVOLVEMENT.
A HEALTHCARE FACILITY IN SWEDEN REPORTED VIA A FISHER AND PAYKEL (F&P) HEALTHCARE FIELD REPRESENTATIVE THAT THE CONNECTION OF THE 950N81 NEONATAL VENTILATOR DUAL HEATED CIRCUIT KIT TO THE PRESSURE LINE WOULD DETACH. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2023864 | FISHER & PAYKEL HEALTHCARE | BREATHING CIRCUIT | BTT | FISHER & PAYKEL HEALTHCARE LTD | 950N81 | 09420012450029 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |