FISHER & PAYKEL HEALTHCARE
Report
- Report Number
- 9611451-2025-00604
- Event Type
- Malfunction
- Date Received
- June 30, 2025
- Date of Event
- May 3, 2025
- Report Date
- July 30, 2025
- Manufacturer
- FISHER & PAYKEL HEALTHCARE LTD
- Product Code
- BZE
- UDI-DI
- 09420012431158
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TH
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(6). 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: THE SUBJECT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER PROVIDED WITH THE RT268 INFANT EVAQUA2 BREATHING CIRCUIT HAS 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)(4). CORRECTIONS: SECTION B4: FIELD UPDATED TO THE DATE OF THIS REPORT. SECTION D4: SERIAL NUMBER INTENTIONALLY LEFT BLANK AS THE INFORMATION IS NOT APPLICABLE. SECTION D4: BATCH# AND UDI NOT INCLUDED AS THE DEVICE DETAILS WERE NOT PROVIDED BY THE HEALTHCARE FACILITY. 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. METHOD: THE SUBJECT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER AS PART OF THE RT268 INFANT EVAQUA2 BREATHING CIRCUIT, WAS NOT RETURNED TO FISHER & PAYKEL (F&P) HEALTHCARE FOR EVALUATION. OUR INVESTIGATION IS BASED ON THE INFORMATION, PHOTOGRAPH AND DESCRIPTION OF EVENTS PROVIDED BY THE HEALTHCARE FACILITY, PREVIOUS INVESTIGATIONS OF SIMILAR COMPLAINTS AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: VISUAL INSPECTION OF THE PROVIDED PHOTOGRAPH REVEALED THAT THE MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER AS PART OF THE RT268 INFANT EVAQUA2 BREATHING CIRCUIT WAS LEAKING BETWEEN THE CHAMBER DOME AND BASE. THERE WAS NO VISIBLE DAMAGE TO THE DOME OR BASE FROM THE PROVIDED PHOTO. CONCLUSION: OUR INVESTIGATION WAS UNABLE TO DETERMINE THE EXACT CAUSE OF THE OBSERVED DAMAGE TO THE MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER AS PART OF THE RT268 INFANT EVAQUA2 BREATHING CIRCUIT. THE USER INSTRUCTIONS PROVIDED WITH THE RT268 BREATHING CIRCUIT INCLUDE THE FOLLOWING: "DO NOT USE THE CHAMBER IF THE SEALS ARE NOT INTACT OF IF IT HAS BEEN DROPPED." "VISUALLY INSPECT BREATHING SETS FOR DAMAGE (E.G. A CRUSHED TUB OR CRACKED CONNECTOR) BEFORE USE AND REPLACE IF DAMAGED." "DO NOT SOAK, WASH, STERILIZE, OR REUSE THIS PRODUCT. AVOID CONTACT WITH CHEMICALS, CLEANING AGENTS, OR HAND SANITIZERS." "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."
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN THAILAND THAT AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER PROVIDED WITH AN RT268 INFANT EVAQUA2 BREATHING CIRCUIT WAS FOUND LEAKING WATER PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT.
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN THAILAND THAT AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER PROVIDED WITH AN RT268 INFANT EVAQUA2 BREATHING CIRCUIT WAS FOUND LEAKING WATER PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT AS THE ISSUE WAS FOUND WHILST THE DEVICE WAS NOT IN USE ON A PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1214810 | FISHER & PAYKEL HEALTHCARE | BREATHING CIRCUIT | BZE | FISHER & PAYKEL HEALTHCARE LTD | RT268 | 2103486237 | 09420012431158 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |