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

Model Number	RD1300-10
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).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.
Event or Problem Description
A healthcare facility in france reported that valves of 4 units rd1300 neopuff t-piece circuits were faulty.There was no reported patient involvement.
Event or Problem Description
A healthcare facility in france reported via a fisher & paykel healthcare (f&p) field representative that peep valve of 4 units of rd1300-10 neopuff t-piece circuits were difficult to rotate.There was no reported patient involvement.
Additional Manufacturer Narrative
(b)(4).Correction: section b5: updated the describe event or problem.The healthcare facility further reported that they have tested (b)(4) units of the rd1300-10 with batch 2103253995 and found the faulty peep valve, difficult to rotate.It was further reported that the patient had to be resuscitated for longer time.Method: the subject device, 33 units of rd1300-10 neopuff t-piece circuit were returned to fisher & paykel healthcare (f&p) in new zealand for evaluation.Our investigation is thus based on the analysis of the returned devices, information and description of events provided by the healthcare facility, and our knowledge of the product.Results: during visual inspection and testing of the subject devices, the peep valve was found to be tight and hard to rotate it both clockwise and anticlockwise directions, confirming the reported failure.Although, the valve was found to be tight, the peep pressure can be set, and the circuits passed functional testing.The dimensional measurements of the t-piece cap and t-piece peep port adaptor were measured and these were found to be within the specifications.Further investigation has confirmed that the incompatible peep valve cavities were used to manufacture the subject devices.Conclusion: the cause of the reported failure is due to the use of an incompatible valve cavity during manufacturing of the subject circuits.As a corrective action, a new tool is being developed and planned to be released to manufacture the rd1300-10 neopuff t-piece circuits in august 2025 to accommodate all cavity variants.As a containment action, the cavity variants will be received as sorted from supplier and will be used accordingly to manufacture the rd1300-10 neopuff t-piece circuits.The rd1300-10 neopuff t-piece circuit is a single use breathing circuit intended to provide ventilatory support to neonates and infants with respiratory insufficiency.The device is designed to connect to the f&p neopuff t-piece resuscitator or any other gas-powered resuscitator compliant to iso-10651- 5:2006.The user instructions that accompany the rd1300 neopuff t-piece circuit state the following: "ensure pressures are monitored throughout resuscitation." " test resuscitator function with the blue cap in place or after connecting the test lung to the t-piece circuit.Test before using on the patient.".

• 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 ; 9494341005
• MDR Report Key: 20808223
• Report Number: 9611451-2024-00884
• Device Sequence Number: 18599568
• Product Code: BTL
• UDI-Device Identifier: 09420012429988
• UDI-Public: (01)09420012429988(10)2103253995(11)240724(17)270724
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K892885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• 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: RD1300-10
• Device Catalogue Number: RD1300-10
• Device Lot Number: 2103253995
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2024
• Supplement Date Received by Manufacturer: 03/03/2025
• Initial Report FDA Received Date: 11/28/2024
• Supplement Report FDA Received Date: 04/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2024
• 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