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
Event or Problem Description
A healthcare facility in france reported that the valves of 42 units rd1300 neopuff t-piece circuits were not moving.There were no reported patient consequences.
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 rd1300 neopuff t-piece circuits were not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is based on the information and photography provided by the healthcare facility and our knowledge of our product.Results: the customer reported that 42 units of the rd1300 neopuff t-piece circuits valve was unable to be moved.Visual inspection of the photograph provided by the healthcare facility was unable to determine the tightness of the peak expiratory end pressure (peep) cap and the cavity of the cap.Conclusion: without the subject device, we are unable to determine the exact cause of the reported fault.The neopuff is a portable, reusable device used to assist in the delivery of respiratory breaths to infants until adequate spontaneous breathing occurs.Being a portable device, the neopuff can be susceptible to impact damage, for instance when accidentally dropped or subjected to considerable external force.The neopuff technical manual warns against dropping the neopuff or subjecting it to impact damage which may cause the unit to operate incorrectly.If the neopuff is suspected to have been damaged, the manometer and valve system should be performance tested.In addition, the neopuff user instructions state that the user should "check manometer reads zero with no gas flow" and check the pressure settings "prior to every use of the neopuff".As mentioned, the neopuff technical manual states the following: dropping the neopuff / perivent infant resuscitator or other similar forms of impact may cause damage resulting in incorrect operation of the unit.If you suspect damage to have occurred, please perform checks as outlined [in the manual] before connection to a patient.Each neopuff unit is assembled and 100% tested in the production line to verify that each unit conforms to critical product specifications.Any unit that fails is rejected.The subject neopuff would have met the requirements at the time of production.
Event or Problem Description
A healthcare facility in france reported that the valves of 42 rd1300 neopuff t-piece circuits units could not be moved.There were no reported patient consequences.
Event or Problem Description
A healthcare facility in france reported that the valves of 42 rd1300 neopuff t-piece circuits units could not be moved.There were no reported patient consequences.
Additional Manufacturer Narrative
(b)(4).Correction: section h11: additional manufacturer narrative is corrected.Section h6: investigation findings and investigation conclusions are corrected.Method: the subject device, rd1300-10 neopuff t-piece circuit was returned to fisher and paykel healthcare (f&p) in new zealand for evaluation.Our investigation is thus based on the analysis of the returned device, 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 device, 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.Further investigation has confirmed that the compatible peep valve cavities were used to manufacture the subject device.Conclusion: we are unable to determine the exact cause of the reported event.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 92618 ; 9494341005
• MDR Report Key: 20768476
• Report Number: 9611451-2024-00801
• Device Sequence Number: 18457628
• Product Code: BTL
• UDI-Device Identifier: 09420012429988
• UDI-Public: (01)09420012429988(10)2103249644(11)240722(17)270722
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/29/2024

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: 2103249644
• 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: 10/29/2024
• Supplement Date Received by Manufacturer: 01/29/2025; 04/08/2025
• Initial Report FDA Received Date: 11/24/2024
• Supplement Report FDA Received Date: 02/25/2025; 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2024
• 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