FISHER & PAYKEL HEALTHCARE
Report
- Report Number
- 9611451-2025-00870
- Event Type
- Malfunction
- Date Received
- September 14, 2025
- Date of Event
- August 22, 2025
- Report Date
- December 2, 2025
- Manufacturer
- FISHER & PAYKEL HEALTHCARE LTD
- Product Code
- BZE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(6). SECTION D4: DEVICE INDENTIFICATION DETAILS WERE NOT RECEIVED. SECTION G4: THE 950A81 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 RT265 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT IS CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE IN NEW ZEALAND FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.
(B)(4). SECTION D4: DEVICE INDENTIFICATION DETAILS WERE NOT RECEIVED. SECTION G4: THE 950A81 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 HUMIDIFICATION CHAMBER PROVIDED AS PART OF THE 950A81 NEONATAL VENTILATOR DUAL HEATED CIRCUIT KIT, WAS RETURNED TO FISHER & PAYKEL (F&P) HEALTHCARE IN NEW ZEALAND WHERE IT WAS VISUALLY INSPECTED. OUR INVESTIGATION IS THEREFORE BASED ON THE EVALUATION OF THE SUBJECT DEVICE, THE INFORMATION PROVIDED BY THE HEALTHCARE FACILITY AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: VISUAL INSPECTION OF THE RETURNED DEVICE IDENTIFIED THAT THE WATER FEEDSET TUBE AT THE CHAMBER END OF THE HUMIDIFICATION CHAMBER WAS TORN. NO FURTHER DAMAGE TO THE SUBJECT HUMIDIFICATION CHAMBER WAS OBSERVED. CONCLUSION: OUR INVESTIGATION WAS UNABLE TO DETERMINE THE EXACT CAUSE OF THE OBSERVED DAMAGE TO THE WATER FEEDSET OF THE RETURNED HUMIDIFICATION CHAMBER. EVERY HUMIDIFICATION CHAMBER IS PRESSURE TESTED FOLLOWING THE MANUFACTURING PROCESS TO CHECK FOR ANY LEAKS PRESENT IN THE CHAMBER DOME DUE TO CRACKS AND OTHER CAUSES. ANY CHAMBER WHICH FAILS THIS TEST IS REJECTED. IN ADDITION, THE PRESSURE TEST IS FOLLOWED BY A VISUAL INSPECTION OF EACH CHAMBER. ANY CHAMBER THAT FAILS THIS INSPECTION IS REJECTED. THE SUBJECT CHAMBER WOULD HAVE MET THE REQUIRED SPECIFICATION AT THE TIME OF PRODUCTION. OUR USER INSTRUCTIONS THAT ACCOMPANY THE 950A81 NEONATAL VENTILATOR DUAL HEATED CIRCUIT KIT STATE THE FOLLOWING: "DO NOT USE THE CHAMBER IF IT HAS BEEN VISIBLY DAMAGED OR DROPPED." "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." "DO NOT CLEAN OR STERILIZE THIS PRODUCT. AVOID CONTACT WITH CHEMICALS, CLEANING AGENTS, OR HAND SANITIZERS."
A HEALTHCARE FACILITY IN THE UNITED KINGDOM REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE HUMIDIFICATION CHAMBER PROVIDED AS PART OF THE 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT (WITH FILTER) WAS FOUND CRACKED AND LEAKING. THERE WERE NO PATIENT CONSEQUENCES REPORTED.
A HEALTHCARE FACILITY IN THE UNITED KINGDOM REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE HUMIDIFICATION CHAMBER PROVIDED AS PART OF THE 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT (WITH FILTER) WAS FOUND CRACKED AND LEAKING. THERE WERE NO PATIENT CONSEQUENCES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2621346 | FISHER & PAYKEL HEALTHCARE | ADULT VENTILATOR DUAL HEATED CIRCUIT KIT | BZE | FISHER & PAYKEL HEALTHCARE LTD | 950A81 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |