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

Model Number	950N81J
Medical Device Problem Code	Overfill (2404)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare facility in (b)(6) reported via a fisher and paykel healthcare (f&p) representative that the (b)(4) chamber complete autofeed chamber as part of the 950n81j adult ventilator dual heated circuit kit (with filter) was found to have overfilled above the maximum water level line during patient use.It was further reported that the 950n81j adult ventilator dual heated circuit kit (with filter) was used for 13 days before the reported fault was observed.There were no reported patient consequences.
Additional Manufacturer Narrative
(b)(6).We are currently in the process of obtaining further information to determine if the complaint: (b)(4) chamber complete autofeed 900 caused or contributed to the reported event.We will provide a follow up report upon completion of our investigation.
Additional Manufacturer Narrative
(b)(4).Section g4, pma/510(k) number: the 950n81 neonar ventilator dual heated circuit kit (with filter) is not sold in the united states of america (usa) but instead a similar product, 950a81j adult ventilator dual heated circuit kit (with filter) is sold in the usa.Therefore, the 510(k) number for 950n81j neonatal ventilator dual heated circuit kit (with filter) has been used under the section g4.Method: the complaint (b)(4) autofeed chamber as part of the 950n81 neonatal ventilator dual heated circuit kit was returned to fisher & paykel healthcare (f&p) in new zealand for further investigation.The complaint device was visually inspected, water level tests were performed, and the device log file was reviewed.Results: visual inspection of the complaint (b)(4) autofeed chamber as part of the 950n81 neonatal ventilator dual heated circuit kit revealed that there was no damage to the chamber.Water level tests of the chamber revealed that primary float water level was within the expected range.Review of the device log file revealed that there were no alarms.Conclusion: there were no faults found with the complaint (b)(4) chamber and therefore, we cannot confirm the reported event.Every (b)(4) 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 (b)(4) chamber complete autofeed 900 state the following: - "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." - "use usp sterile water for irrigation, or equivalent.Adding other substances may have adverse effects.
Event or Problem Description
A healthcare facility in iowa reported via a fisher and paykel healthcare (f&p) representative that the (b)(4) chamber complete autofeed chamber as part of the 950n81j adult ventilator dual heated circuit kit (with filter) was found to have overfilled above the maximum water level line during patient use.It was further reported that the 950n81j adult ventilator dual heated circuit kit (with filter) was used for 13 days before the reported fault was observed.There were no reported patient consequences.

• Brand Name: FISHER & PAYKEL HEALTHCARE
• Common Device Name: BREATHING CIRCUIT KIT
• 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 vargas banuelos ; 17400 laguna canyon road; suite 300; irvine, CA 92616 ; 9494341005
• MDR Report Key: 21440534
• Report Number: 9611451-2025-00151
• Device Sequence Number: 11913705
• Product Code: BTT
• UDI-Device Identifier: 09420012461216
• UDI-Public: (01)09420012461216(10)2103271359(11)240802(17)270802
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2025

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: 950N81J
• Device Catalogue Number: 950N81J
• Device Lot Number: 2103271359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2025
• Supplement Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 02/22/2025
• Supplement Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2024
• 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: F&P 950 RESPIRATORY HUMIDIFER; F&P 950S02 SENSOR CARTRIDGE
• Patient Sex: Unknown