FISHER & PAYKEL HEALTHCARE
Report
- Report Number
- 9611451-2025-00345
- Event Type
- Malfunction
- Date Received
- April 21, 2025
- Date of Event
- March 20, 2025
- Report Date
- September 17, 2025
- Manufacturer
- FISHER & PAYKEL HEALTHCARE LTD
- Product Code
- BZE
- UDI-DI
- 09420012431158
- PMA / PMN Number
- SEE H11
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4) SECTION D4: THE LOT NUMBERS OF THE REPORTED RT268 INFANT EVAQUA2 BREATHING CIRCUITS ARE: 2103251807, 2103056191. SECTION G4: THE RT268 INFANT EVAQUA2 BREATHING CIRCUIT 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 K103767. THE SUBJECT RT268 INFANT EVAQUA2 BREATHING CIRCUITS HAVE BEEN REQUESTED TO BE RETURNED TO FISHER & PAYKEL (F&P) HEALTHCARE IN NEW ZEALAND FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.
(B)(6). SECTION D4: THE LOT NUMBERS OF THE REPORTED RT268 INFANT EVAQUA2 BREATHING CIRCUITS ARE: - 2103251807. - 2103056191. SECTION H4: THE DEVICE MANUFACTURER DATE OF THE REPORTED RT268 INFANT EVAQUA2 BREATHING CIRCUITS ARE: - 23 JUL 2024 (LOT 2103251807). - 25 MAR 2024 (LOT 2103056191). SECTION G4: THE RT268 INFANT EVAQUA2 BREATHING CIRCUIT 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 K103767. SECTION H11: METHOD: THE SUBJECT TEMPERATURE/FLOW PROBES, RT268 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUITS, AND ADDITIONAL INFORMATION ABOUT THE REPORTED EVENT WERE REQUESTED TO BE PROVIDED TO FISHER & PAYKEL (F&P) HEALTHCARE NEW ZEALAND FOR EVALUATION. IN ADDITION, A REVIEW OF THE MANUFACTURING RECORDS FOR THE REPORTED DEVICES WAS COMPLETED. RESULTS: THE HEALTHCARE FACILITY REPORTED THAT BOTH THE TEMPERATURE/FLOW PROBES AND THEIR IDENTIFYING INFORMATION WERE NOT AVAILABLE. THE SUBJECT RT268 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUITS WERE RECEIVED AT FISHER & PAYKEL HEALTHCARE (F&P) IN NEW ZEALAND FOR EVALUATION, WHERE THEY WERE VISUALLY INSPECTED. VISUAL INSPECTION OF THE RETURNED DEVICES IDENTIFIED NO VISIBLE DAMAGE OR DEFECTS. A REVIEW OF THE MANUFACTURING RECORDS OF THE LOT BATCHES OF THE RT268 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUITS WAS ALSO PERFORMED. THE DEVICES IN THE MANUFACTURING LOTS PASSED ALL THE REQUIRED QUALITY CONTROL MEASURES, CONFIRMING THEY WERE MANUFACTURED IN ACCORDANCE WITH SPECIFICATIONS. ADDITIONALLY, NO NON-CONFORMANCES WERE NOTED DURING THE MANUFACTURING PROCESS OF THE SUBJECT LOTS. CONCLUSION: BASED ON THE INFORMATION PROVIDED BY THE HEALTHCARE FACILITY, OUR INVESTIGATION, AND REVIEW OF THE MANUFACTURING RECORDS, WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED ISSUE. AS PART OF DESIGN VALIDATION AND VERIFICATION ACTIVITIES, ALL F&P HEALTHCARE PRODUCTS ARE TESTED TO ENSURE THEY MEET DOCUMENTED PRODUCT REQUIREMENTS AND SPECIFICATIONS. AT THE END OF THE FINAL ASSEMBLY PROCESS, ALL RT268 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUITS ARE 100% TESTED AS FOLLOWS: - FUNCTIONAL TESTING FOR LEAK - VISUAL INSPECTIONS FOR ANY VISIBLE DEFECTS AND CONTAMINATION - RESISTANCE TESTING OF THE HEATER WIRE THE INSTRUCTIONS FOR USE ACCOMPANYING THE RT268 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUITS SHOW IN PICTORIAL FORMAT THE CORRECT SET-UP OF THE CIRCUIT AND ALSO STATE THE FOLLOWING: - ENSURE APPROPRIATE VENTILATOR OR FLOW SOURCE ALARMS ARE SET BEFORE CONNECTING BREATHING SET TO PATIENT - PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT. - CHECK ALL CONNECTIONS ARE TIGHT BEFORE USE - 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. THE INSTRUCTIONS FOR USE ACCOMPANYING EACH MR850 RESPIRATORY HUMIDIFIER OUTLINES THE CORRECT SET-UP OF THE DEVICE IN ACCORDANCE WITH INSTRUCTIONS AND WARNINGS, AND ALSO STATES THE FOLLOWING: - ENSURE THAT BOTH TEMPERATURE PROBE SENSORS ARE CORRECTLY AND SECURELY FITTED. - VISUALLY INSPECT THE HUMIDIFIER AND ACCESSORIES FOR DAMAGE BEFORE USE AND REPLACE IF DAMAGED - THIS PRODUCT IS FOR USE UNDER THE SUPERVISION OF TRAINED MEDICAL PERSONNEL. - ENSURE THAT APPROPRIATE VENTILATOR AND/OR PATIENT MONITOR ALARMS ARE SET, CONNECTIONS ARE SECURE AND A LEAK TEST IS COMPLETED BEFORE USE. THE MR850 TECHNICAL MANUAL ALSO OUTLINES THE ACTION REQUIRED WHEN A FLASHING 'AIRWAY PROBE' INDICATOR IS ACCOMPANIED BY AN AUDIBLE ALARM, INCLUDING TO 'CHECK FOR PROPER INSERTION OF THE AIRWAY PROBE INTO A CORRECTLY CONFIGURED BREATHING CIRCUIT', AND TO 'ADJUST AS NECESSARY'. THE TECHNICAL MANUALS ALSO OUTLINE THE 6 MONTHLY AND ANNUAL MAINTENANCE TASKS TO ENSURE THE HUMIDIFIER, AND ITS ACCESSORIES ARE IN WORKING ORDER. IN ADDITION, IT ALSO STATES THAT THE ACCESSORIES USED WITH THE MR850 RESPIRATORY HUMIDIFIER ARE TO BE VISUALLY AND FUNCTIONALLY CHECKED AND REPLACED IN THE CASE OF DAMAGE OR IF IT FAILS THE PERFORMANCE TEST.
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN JAPAN, VIA A FISHER & PAYKEL (F&P) HEALTHCARE FIELD REPRESENTATIVE, THAT TEMPERATURE/FLOW PROBES WERE IDENTIFIED TO BE LOOSE AT THE PATIENT-END TEMPERATURE PROBE PORT OF SEVEN RT268 INFANT EVAQUA2 BREATHING CIRCUITS PRIOR TO PATIENT USE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN JAPAN, VIA A FISHER & PAYKEL (F&P) HEALTHCARE FIELD REPRESENTATIVE, THAT TEMPERATURE/FLOW PROBES WERE IDENTIFIED TO BE LOOSE AT THE PATIENT-END TEMPERATURE PROBE PORT OF SEVEN RT268 INFANT EVAQUA2 BREATHING CIRCUITS PRIOR TO PATIENT USE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1726625 | FISHER & PAYKEL HEALTHCARE | BREATHING CIRCUIT | BZE | FISHER & PAYKEL HEALTHCARE LTD | RT268 | SEE H11 | 09420012431158 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | TEMPERATURE PROBES (DETAILS NOT PROVIDED).| TEMPERATURE PROBES (DETAILS NOT PROVIDED). |