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

Model Number	950N81J
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Method: the subject 950n81j neonatal ventilator dual heated circuit kit (with accessories) was received at fisher & paykel healthcare (f&p) new zealand for investigation where it was visually inspected and gas leakage tested.Our investigation is thus based on our evaluation of the subject device and our knowledge of the product.Results: visual inspection of the subject device observed that the tubing had visible damage to the t-seal on the inspiratory chamber end connector.The returned dual limb was also gas leakage tested and failed, confirming the reported fault.Conclusion: our investigation was unable to determine the exact cause of the observed damage to the 950n81j neonatal ventilator dual heated circuit kit.The user instructions which accompanies the 950n81j neonatal ventilator dual heated circuit kit cautions the user: do not crush, stretch, or milk the tubing.Check all connections are tight before use.Perform a pressure and leak test on the breathing system before connecting to a patient.
Event or Problem Description
During device evaluation of a 950n81j neonatal ventilator dual heated circuit kit (with accessories) at fisher & paykel healthcare (f&p) new zealand, it was found that inspiratory limb failed the gas leakage test due to a severe leak.There was no patient involvement as the issue was found whilst the device was not in use on a patient.

• 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 banuelos ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494341005
• MDR Report Key: 21999947
• Report Number: 9611451-2025-00420
• Device Sequence Number: 15800315
• Product Code: BTT
• UDI-Device Identifier: 09420012461216
• UDI-Public: (01)09420012461216(10)2103238178(11)240715(17)270715
• 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
• Report Date (Section B): 04/16/2025

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: 2103238178
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2025
• Initial Report FDA Received Date: 05/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2024
• 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
• Patient Sex: Unknown