VENTED HUMIDIFICATION CHAMBER
Report
- Report Number
- 9611451-2022-00703
- Event Type
- Malfunction
- Date Received
- August 2, 2022
- Date of Event
- June 29, 2022
- Report Date
- July 5, 2022
- Manufacturer
- FISHER & PAYKEL HEALTHCARE LTD
- Product Code
- BTT
- PMA / PMN Number
- K934140
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IS
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4). THE COMPLAINT MR290VX AUTOFEED VENTED HUMIDIFICATION CHAMBERS ARE CURRENTLY EN-ROUTE TO FISHER & PAYKEL HEALTHCARE (F&P) FOR EVALUATION. WE WILL SEND A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.
(B)(4). ADDITIONAL INFORMATION RECEIVED: CHANGES MADE TO SECTIONS B5, H10 - SINCE THE FINAL REPORT WAS PROVIDED, THE CUSTOMER RETURNED AN ADDITIONAL THREE CHAMBERS RELATED TO THIS REPORTED EVENT FOR INVESTIGATION. NO FURTHER INFORMATION WAS PROVIDED ON THE DATE, SEQUENCE OF EVENTS OR PATIENT OUTCOMES. INVESTIGATION OF THE THREE RETURNED CHAMBERS CONFIRMED A HORIZONTAL CRACK NEAR THE CHAMBER BASE. THESE THREE CHAMBERS EXHIBIT THE SAME DEFECT PATTERN AS THE PREVIOUS FIVE CHAMBERS. SECTION D4: BATCH NUMBERS OF THE RETURNED DEVICES DEVICE 1 - 210825, DEVICE 2 - 210905, DEVICE 3 - 210905, DEVICE 4 - 210905, DEVICE 5 - 210825, DEVICE 6 - 210824, DEVICE 7 - 190713, DEVICE 8 - 210818. METHOD: IN TOTAL, EIGHT COMPLAINT MR290VX VENTED AUTOFEED HUMIDIFICATION CHAMBERS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE IN NEW ZEALAND FOR INVESTIGATION FOR EVALUATION, WHERE THEY WERE VISUALLY INSPECTED AND ANALYSED. RESULTS: VISUAL INSPECTION IDENTIFIED HORIZONTAL CRACKS BETWEEN THE CHAMBER BASE AND THE MAXIMUM WATER LEVEL LINE. INK SMUDGES WERE FOUND ON THE PRINTED AREA WHERE THE CRACKS WERE OBSERVED. ANALYSIS OF THE CONNECTION BETWEEN THE CHAMBER BASE AND DOME WAS CONDUCTED AND THERE WERE NO DEFECTS IDENTIFIED THAT WOULD HAVE CONTRIBUTED TO CRACKED CHAMBER DOMES. CONCLUSION: WE ARE UNABLE TO DETERMINE THE CAUSE OF THE CHAMBER CRACKS. HOWEVER, BASED ON OUR INVESTIGATION, IT IS MOST LIKELY DUE TO EXTERNALLY APPLIED MECHANICAL STRESS. EVERY MR290VX 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 MR290VX CHAMBERS WOULD HAVE MET THE REQUIRED SPECIFICATION AT THE TIME OF PRODUCTION. OUR USER INSTRUCTIONS THAT ACCOMPANY THE MR290VX VENTED AUTOFEED HUMIDIFICATION CHAMBER 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." "USE OF THE MR290 ABOVE THE MAXIMUM OPERATING PRESSURE MAY LEAD TO CRACKING, WATER LEAKAGE AND, ON RARE OCCASIONS COULD LEAD TO A LOSS OF VENTILATION PRESSURE."
(B)(4), SECTION D4: BATCH NUMBERS OF THE RETURNED DEVICES DEVICE 1 - 210825 0304, DEVICE 2 - 210905 1144, DEVICE 3 - 210905 0849, DEVICE 4 - 210905 0926, DEVICE 5 - 210825 0147. METHOD: FIVE COMPLAINT MR290VX VENTED AUTOFEED HUMIDIFICATION CHAMBERS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE IN NEW ZEALAND FOR INVESTIGATION FOR EVALUATION, WHERE THEY WERE VISUALLY INSPECTED AND ANALYSED. RESULTS: VISUAL INSPECTION IDENTIFIED HORIZONTAL CRACKS BETWEEN THE CHAMBER BASE AND THE MAXIMUM WATER LEVEL LINE. INK SMUDGES WERE FOUND ON THE PRINTED AREA WHERE THE CRACKS WERE OBSERVED. ANALYSIS OF THE CONNECTION BETWEEN THE CHAMBER BASE AND DOME WAS CONDUCTED AND THE MEASUREMENTS WERE CONFIRMED TO BE WITHIN SPECIFICATION. CONCLUSION: WE ARE UNABLE TO DETERMINE THE CAUSE OF THE CHAMBER CRACKS. HOWEVER, BASED ON OUR INVESTIGATION, IT IS MOST LIKELY DUE TO EXTERNALLY APPLIED MECHANICAL STRESS. EVERY MR290VX 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 MR290VX CHAMBERS WOULD HAVE MET THE REQUIRED SPECIFICATION AT THE TIME OF PRODUCTION. OUR USER INSTRUCTIONS THAT ACCOMPANY THE MR290VX VENTED AUTOFEED HUMIDIFICATION CHAMBER 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. USE OF THE MR290 ABOVE THE MAXIMUM OPERATING PRESSURE MAY LEAD TO CRACKING, WATER LEAKAGE AND, ON RARE OCCASIONS COULD LEAD TO A LOSS OF VENTILATION PRESSURE."
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN ISRAEL VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THREE MR290VX VENTED AUTOFEED HUMIDIFICATION CHAMBERS WERE FOUND TO BE LEAKING WATER DURING PATIENT USE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN ISRAEL VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT SEVERAL MR290VX VENTED AUTOFEED HUMIDIFICATION CHAMBERS WERE FOUND TO BE LEAKING WATER DURING PATIENT USE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN ISRAEL VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THREE MR290VX VENTED AUTOFEED HUMIDIFICATION CHAMBERS WERE FOUND TO BE LEAKING WATER DURING PATIENT USE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1412017 | VENTED HUMIDIFICATION CHAMBER | AUTOFEED CHAMBER | BTT | FISHER & PAYKEL HEALTHCARE LTD | MR290VX | SEE H10 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |