FISHER & PAYKEL HEALTHCARE
Report
- Report Number
- 9611451-2026-00108
- Event Type
- Malfunction
- Date Received
- January 8, 2026
- Date of Event
- December 11, 2025
- Report Date
- May 12, 2026
- Manufacturer
- FISHER & PAYKEL HEALTHCARE LTD
- Product Code
- BTT
- UDI-DI
- 09420012436825
- PMA / PMN Number
- K220703
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
(B)(4). SECTION G4: 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT 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 K220703. FISHER & PAYKEL (F&P) HEALTHCARE ARE CURRENTLY IN THE PROCESS OF OBTAINING FURTHER INFORMATION REGARDING THE REPORTED EVENT. WE HAVE ALSO REQUESTED THE RETURN OF THE SUBJECT 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT TO F&P HEALTHCARE NEW ZEALAND FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.
(B)(4). CORRECTIONS: SECTION G4: 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT 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 K220703. METHOD: THE SUBJECT 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT WAS RETURNED TO FISHER & PAYKEL (F&P) HEALTHCARE FOR EVALUATION IN NEW ZEALAND WHERE IT WAS VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION OF THE RETURNED 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT IDENTIFIED THAT THE INSPIRATORY LIMB WAS DAMAGED, CONFIRMING THE REPORTED ISSUE. THE DAMAGE OBSERVED, APPEARS LIKE THE INSPIRATORY LIMB HAD BEEN AXIALLY CUT OPEN. CONCLUSION: THE REPORTED DAMAGE TO THE SUBJECT 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT WAS CONFIRMED. F&P HEALTHCARE'S INVESTIGATION WAS UNABLE TO DETERMINE THE ROOT CAUSE OF THE SPLIT TUBING. ALL 950A81 ADULT VENTILATOR DUAL HEATED BREATHING CIRCUITS ARE 100% LEAK TESTED DURING PRODUCTION, AND THOSE THAT FAIL ARE REJECTED. THE SUBJECT 950A81 BREATHING CIRCUIT WOULD HAVE MET THE REQUIRED SPECIFICATIONS AT THE TIME OF PRODUCTION. THE USER INSTRUCTIONS WHICH ACCOMPANY THE 950A81 ADULT VENTED DUAL HEATED CIRCUIT KIT STATE THE FOLLOWING: -APPROPRIATE PATIENT MONITORING (E.G. OXYGEN SATURATION) MUST BE USED AT ALL TIMES. FAILURE TO MONITOR THE PATIENT (E.G. IN THE EVENT OF AN INTERRUPTION TO GAS FLOW) MAY RESULT IN SERIOUS HARM OR DEATH. -SINGLE USE. DO NOT REUSE THIS PRODUCT. REUSE MAY RESULT IN TRANSMISSION OF INFECTIOUS SUBSTANCES, INTERRUPTION TO TREATMENT, SERIOUS HARM, OR DEATH. -DO NOT CRUSH, STRETCH, OR MILK THE TUBING. -DO NOT CLEAN OR STERILIZE THIS PRODUCT. AVOID CONTACT WITH CHEMICALS, CLEANING AGENTS, OR HAND SANITIZERS. -PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM BEFORE CONNECTING TO A PATIENT -CHECK ALL CONNECTIONS ARE TIGHT BEFORE USE.
A HEALTHCARE FACILITY IN FRANCE REPORTED VIA A FISHER & PAYKEL (F&P) HEALTHCARE FIELD REPRESENTATIVE THAT THE 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT WAS LEAKING AIR DURING PATIENT USE. UPON INSPECTION, THE HEALTHCARE FACILITY IDENTIFIED A CRACK ON THE INSPIRATORY LIMB OF THE DEVICE. THERE WAS NO REPORTED PATIENT HARM.
A HEALTHCARE FACILITY IN FRANCE REPORTED VIA A FISHER & PAYKEL (F&P) HEALTHCARE FIELD REPRESENTATIVE THAT THE 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT WAS LEAKING AIR DURING PATIENT USE. UPON INSPECTION, THE HEALTHCARE FACILITY IDENTIFIED A CRACK ON THE INSPIRATORY LIMB OF THE DEVICE. THERE WAS NO REPORTED PATIENT HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 510165 | FISHER & PAYKEL HEALTHCARE | BREATHING CIRCUIT | BTT | FISHER & PAYKEL HEALTHCARE LTD | 950A81 | 2103800477 | 09420012436825 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |