FISHER & PAYKEL HEALTHCARE
Report
- Report Number
- 9611451-2024-00437
- Event Type
- Malfunction
- Date Received
- June 21, 2024
- Date of Event
- May 22, 2024
- Report Date
- May 23, 2024
- Manufacturer
- FISHER & PAYKEL HEALTHCARE LTD
- Product Code
- BZE
- UDI-DI
- 09420012431080
- PMA / PMN Number
- K020332
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4). CORRECTIONS: SECTION B5: UPDATED. SECTION D1: BRAND NAME UPDATED TO FISHER & PAYKEL HEALTHCARE. SECTION D2A: COMMON DEVICE NAME UPDATED TO BREATHING CIRCUIT. SECTION D2B: PRODUCT CODE UPDATED TO BZE. SECTION D4: DEVICE DETAILS UPDATED. SECTION G4: PMA/510(K) NUMBER UPDATED. SECTION G3: DATE CORRECTED. SECTION H11: METHOD: THE SUBJECT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER WAS NOT RETURNED TO FISHER & PAYKEL (F&P) HEALTHCARE IN NEW ZEALAND FOR EVALUATION. OUR INVESTIGATION IS THEREFORE BASED ON THE INFORMATION AND PHOTOGRAPHS PROVIDED BY THE HEALTHCARE FACILITY, AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: A REVIEW OF THE PROVIDED PHOTOGRAPHS CONFIRMS THE PRESENCE OF A CRACK ON THE SIDE OF THE CHAMBER'S DOME. CONCLUSION: BASED ON THE INFORMATION PROVIDED BY THE HEALTHCARE FACILITY AND WITHOUT THE RETURN OF THE SUBJECT DEVICE, WE ARE UNABLE TO DETERMINE THE CAUSE OF THE CRACK. EVERY MR290V HUMIDIFICATION CHAMBER IS PRESSURE TESTED FOLLOWING THE MANUFACTURING PROCESS AND ANY HOLES, CRACKS, OR LEAKS WOULD BE IDENTIFIED DURING THIS PROCESS. IN ADDITION, THE PRESSURE TEST IS FOLLOWED BY A VISUAL INSPECTION OF EACH CHAMBER. ANY CHAMBER WHICH FAILS THESE TESTS IS REJECTED. THE SUBJECT MR290V HUMIDIFICATION CHAMBER WOULD HAVE MET THE REQUIRED SPECIFICATIONS AT THE TIME OF PRODUCTION. THE USER INSTRUCTIONS THAT ACCOMPANY THE RT225 INFANT VENTILATOR CIRCUIT STATE THE FOLLOWING: DO NOT USE THE CHAMBER IF THE SEALS ARE NOT INTACT WHEN RECEIVED, OR IF IT HAS BEEN DROPPED. VISUALLY INSPECT BREATHING SETS FOR DAMAGE (E.G. CRUSHED TUBE OR CRACKED CONNECTOR) BEFORE USE AND REPLACE IF DAMAGED. ENSURE APPROPRIATE VENTILATOR AND FLOW SOURCE ALARMS ARE SET BEFORE CONNECTING BREATHING SET TO PATIENT. DO NOT SOAK, WASH, STERILIZE, OR REUSE THIS PRODUCT. AVOID CONTACT WITH CHEMICALS, CLEANING AGENTS, OR HAND SANITIZERS. PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT. ENSURE THERE IS A WATER SUPPLY CONNECTED TO THE CHAMBER AND THAT WATER IS PRESENT IN THE CHAMBER.
(B)(4). CORRECTION: SECTION D9: NO. DEVICE NOT AVAILABLE FOR EVALUATION. SECTION G2: ADDED OTHER REGULATORY AUTHORITY (NMPA) . SECTION H11: METHOD: THE SUBJECT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER WAS NOT RETURNED TO FISHER & PAYKEL (F&P) HEALTHCARE IN NEW ZEALAND FOR EVALUATION. OUR INVESTIGATION IS THEREFORE BASED ON THE INFORMATION AND PHOTOGRAPHS PROVIDED BY THE HEALTHCARE FACILITY, AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: A REVIEW OF THE PROVIDED PHOTOGRAPHS CONFIRMS THE PRESENCE OF A CRACK ON THE SIDE OF THE CHAMBER'S DOME. CONCLUSION: BASED ON THE INFORMATION PROVIDED BY THE HEALTHCARE FACILITY AND WITHOUT THE RETURN OF THE SUBJECT DEVICE, WE ARE UNABLE TO DETERMINE THE CAUSE OF THE CRACK. EVERY MR290V HUMIDIFICATION CHAMBER IS PRESSURE TESTED FOLLOWING THE MANUFACTURING PROCESS AND ANY HOLES, CRACKS, OR LEAKS WOULD BE IDENTIFIED DURING THIS PROCESS. IN ADDITION, THE PRESSURE TEST IS FOLLOWED BY A VISUAL INSPECTION OF EACH CHAMBER. ANY CHAMBER WHICH FAILS THESE TESTS IS REJECTED. THE SUBJECT MR290V HUMIDIFICATION CHAMBER WOULD HAVE MET THE REQUIRED SPECIFICATIONS AT THE TIME OF PRODUCTION. THE USER INSTRUCTIONS THAT ACCOMPANY THE MR290V HUMIDIFICATION CHAMBER STATE THE FOLLOWING: - DO NOT USE THE CHAMBER IF THE SEALS ARE NOT INTACT WHEN RECEIVED, OR IF IT HAS BEEN DROPPED. - VISUALLY INSPECT BREATHING SETS FOR DAMAGE (E.G. CRUSHED TUBE OR CRACKED CONNECTOR) BEFORE USE AND REPLACE IF DAMAGED. - ENSURE APPROPRIATE VENTILATOR AND FLOW SOURCE ALARMS ARE SET BEFORE CONNECTING BREATHING SET TO PATIENT. - DO NOT SOAK, WASH, STERILIZE, OR REUSE THIS PRODUCT. AVOID CONTACT WITH CHEMICALS, CLEANING AGENTS, OR HAND SANITIZERS. - PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT. - ENSURE THERE IS A WATER SUPPLY CONNECTED.
(B)(4). THE SUBJECT MR290 VENTED AUTOFEED HUMIDIFICATION CHAMBER HAS BEEN REQUESTED TO BE RETURNED TO FISHER & PAYKEL HEALTHCARE IN NEW ZEALAND FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.
A HEALTHCARE FACILITY IN CHINA REPORTED THAT AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER PROVIDED WITH AN RT225 INFANT VENTILATOR CIRCUIT WAS FOUND LEAKING WATER FROM A CRACK ON THE CHAMBER'S DOME AFTER TWO DAYS OF USE. THE HEALTHCARE FACILITY REPORTED THAT THE PATIENT'S OXYGEN SLIGHTLY DECREASED TO AROUND 85%, HOWEVER NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED.
A HEALTHCARE FACILITY IN CHINA REPORTED THAT A MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER WAS FOUND LEAKING WATER FROM A CRACK ON THE CHAMBER'S DOME AFTER TWO DAYS OF USE. THE HEALTHCARE FACILITY REPORTED THAT THE PATIENT'S OXYGEN SLIGHTLY DECREASED TO AROUND 85%, HOWEVER NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED.
A HEALTHCARE FACILITY IN CHINA REPORTED THAT A MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER WAS FOUND LEAKING WATER FROM A CRACK ON THE CHAMBER'S DOME AFTER TWO DAYS OF USE. THE HEALTHCARE FACILITY REPORTED THAT THE PATIENT'S OXYGEN SLIGHTLY DECREASED TO AROUND 85%, HOWEVER NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 219305 | FISHER & PAYKEL HEALTHCARE | BREATHING CIRCUIT | BZE | FISHER & PAYKEL HEALTHCARE LTD | RT225 | 2102497638 | 09420012431080 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 3 DA | Unknown | RT225 INFANT VENTILATOR CIRCUIT SINGLE HEATED.| RT225 INFANT VENTILATOR CIRCUIT SINGLE HEATED. |