FISHER & PAYKEL HEALTHCARE
Report
- Report Number
- 9611451-2024-00491
- Event Type
- Malfunction
- Date Received
- July 4, 2024
- Report Date
- June 6, 2024
- Manufacturer
- FISHER & PAYKEL HEALTHCARE LTD
- Product Code
- BZE
- UDI-DI
- 09420012429728
- PMA / PMN Number
- K122432
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FI
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4). CORRECTIONS: SECTION D1: BRAND NAME UPDATED TO FISHER & PAYKEL HEALTHCARE. SECTION D2A: COMMON DEVICE NAME UPDATED TO BREATHING CIRCUIT. SECTION D2B: DEVICE PRODUCT CODE UPDATED TO BZE. SECTION D4: MODEL AND CATALOG # UPDATED TO RT380. SECTION G4: PMA/510(K) NUMBER UPDATED TO K122432. SECTION D4 - DEVICE IDENTIFICATION - QUANTITY AFFECTED OF EACH LOT NUMBER WAS NOT RECEIVED: LOT NUMBER: 2102656363, DATE OF MANUFACTURING: 19 JUN 2023, UDI: (B)(4). LOT NUMBER: 2102692453, DATE OF MANUFACTURING: 17 JULY 2023, UDI: (B)(4). METHOD: THE TEN SUBJECT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS PROVIDED WITH TEN RT380 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUITS WERE NOT RETURNED TO FISHER & PAYKEL HEALTHCARE FOR EVALUATION. OUR INVESTIGATION IS THEREFORE BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER, AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: THE HEALTHCARE FACILITY REPORTED THAT THE TEN DEVICES FAILED THE VENTILATOR LEAK TEST PRIOR TO PATIENT USE. CONCLUSION: WITHOUT THE RETURN OF THE SUBJECT DEVICES, WE ARE UNABLE TO DETERMINE THE CAUSE OF THE REPORTED FAILED LEAK TESTS. EVERY MR290 CHAMBER IS PRESSURE TESTED FOLLOWING THE MANUFACTURING PROCESS TO CHECK FOR ANY LEAKS PRESENT IN THE CHAMBER 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. NO CRACKS IN THE CHAMBER DOME ARE ACCEPTABLE. ANY CHAMBER THAT FAILS THIS INSPECTION IS REJECTED. THE SUBJECT MR290 CHAMBER WOULD HAVE MET THE REQUIRED SPECIFICATION AT THE TIME OF PRODUCTION. THE USER INSTRUCTIONS THAT ACCOMPANY THE RT380 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT STATE THE FOLLOWING: - "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." - "VISUALLY INSPECT BREATHING SETS FOR DAMAGE (E.G. CRUSHED TUBE OR CRACKED CONNECTOR) BEFORE USE AND REPLACE IF DAMAGED."
(B)(4). THE SUBJECT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS WERE REQUESTED TO BE PROVIDED TO FISHER & PAYKEL HEALTHCARE NEW ZEALAND FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.
A HEALTHCARE FACILITY IN FINLAND REPORTED THAT TEN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS PROVIDED WITH TEN RT380 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUITS FAILED THE VENTILATOR LEAK TEST PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
A HEALTHCARE FACILITY IN FINLAND REPORTED THAT TEN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS PROVIDED WITH TEN RT380 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUITS FAILED THE VENTILATOR LEAK TEST PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1283033 | FISHER & PAYKEL HEALTHCARE | BREATHING CIRCUIT | BZE | FISHER & PAYKEL HEALTHCARE LTD | RT380 | SEE H11 | 09420012429728 |
| 952899 | FISHER & PAYKEL HEALTHCARE | BREATHING CIRCUIT | BZE | FISHER & PAYKEL HEALTHCARE LTD | RT380 | SEE H11 | 09420012429728 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | DRÄGER EVITA INFINITY V500| DRÄGER EVITA INFINITY V500| DRÄGER EVITA V800| DRÄGER EVITA V800 |