MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD FISHER & PAYKEL HEALTHCARE; BREATHING CIRCUIT

Model Number	950A81J
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare facility in canada reported via a fisher & paykel healthcare (f&p) field representative, that the z41002 autofeed chamber as part of the 950a81j f&p 950¿ adult ventilator dual heated circuit kit (with filter), had a small hole at the base of the chamber causing water to leak.There was no patient consequence.
Additional Manufacturer Narrative
(b)(4).Fisher & paykel healthcare (f&p) is in the process of completing our investigation.We will provide a follow-up report upon completion of our investigation.
Additional Manufacturer Narrative
(b)(4).Method: the subject z41002 autofeed chamber as part of the 950a81j f&p 950 adult ventilator dual heated circuit kit (with filter) was received at fisher & paykel healthcare (f&p) in new zealand for investigation, where it was visually inspected and tested.Our investigation is thus based on the evaluation of the subject device, the information provided by the healthcare facility and our knowledge of the product.Results: the healthcare facility reported that there was a small hole at the base of the subject z41002 autofeed chamber, causing water to leak.Visual inspection of the complaint device revealed white residue on the outside of the chamber base.A hole was observed on the chamber base.The edges of the hole were rough, indicating that the base had eroded.A scanning electron microscopy (sem) analysis was performed.Elemental analysis of the base residue and around the pinhole showed the presence of carbon, oxygen, sodium, aluminium and other trace elements.Conclusion: based on our knowledge of the product and the information provided by the healthcare facility, the cause of the degradation of the z41002 autofeed chamber base, is due to the use of sodium carbonate.When introduced to the subject chamber, this results in the formation of corrosive sodium bicarbonate, which can chemically degrade the aluminium chamber base.Every z41002 chamber complete autofeed 900 is pressure tested following the manufacturing process to check for any leaks present in the chamber dome 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 chamber would have met the required specification at the time of production.Our user instructions that accompany the z41002 chamber complete autofeed 900 state the following: - "use usp sterile water for irrigation, or equivalent.Adding other substances may have adverse effects." - "do not clean or sterilize this product.Avoid contact with chemicals, cleaning agents, or hand sanitizers." - "do not use the chamber if it has been visibly damaged or dropped." - "set appropriate ventilator or flow source alarms to monitor therapy delivery." - "perform a pressure and leak test on the breathing system before connecting to a patient.".
Event or Problem Description
A healthcare facility in canada reported via a fisher & paykel healthcare (f&p) field representative, that the z41002 autofeed chamber as part of the 950a81j f&p 950¿ adult ventilator dual heated circuit kit (with filter), had a small hole at the base of the chamber causing water to leak.There was no patient consequence.

• Brand Name: FISHER & PAYKEL HEALTHCARE
• Common Device Name: BREATHING CIRCUIT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: diego banuelos ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494341005
• MDR Report Key: 20858386
• Report Number: 9611451-2024-00901
• Device Sequence Number: 3864412
• Product Code: BTT
• UDI-Device Identifier: 09420012461148
• UDI-Public: (01)09420012461148(10)2103158180(11)240528(17)270528
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K220703
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 950A81J
• Device Catalogue Number: 950A81J
• Device Lot Number: 2103158180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2024
• Supplement Date Received by Manufacturer: 03/17/2025
• Initial Report FDA Received Date: 12/05/2024
• Supplement Report FDA Received Date: 03/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AEROGEN SOLO NEBULIZER; SERVO-U MAQUET VENTILATOR; SERVO-U MAQUET VENTILATOR; SOKINOX
• Patient Sex: Unknown