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

Model Number	RT329
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	09/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The subject rt329 infant continuous flow circuit has been requested to be returned to fisher & paykel (f&p) healthcare in new zealand for evaluation.We will provide a follow up report upon completion of our investigation.
Event or Problem Description
Fisher & paykel (f&p) healthcare was notified via an fda medwatch form that a healthcare facility in (b)(6) reported that the 'blue cap' of an rt329 infant continuous flow circuit dislodged causing a leak.The healthcare facility reported that as a result, the patient desaturated, and medical intervention was required.F&p healthcare have requested further information about the reported event, including information about the patient condition, sequence of events, and the reported fault with the subject rt329 infant continuous flow circuit.However, no further information has been provided.F&p healthcare will provide a follow up report upon completion of our investigation.
Additional Manufacturer Narrative
(b)(4).Method: fisher & paykel (f&p) healthcare requested the return of the subject rt329 infant continuous flow circuit for evaluation and requested photographs and additional information about the reported event, including information about the patient condition, sequence of events, and the reported fault with the subject rt329 infant continuous flow circuit.Results: there was no response to f&p healthcare's requests for the return of the subject device, photographs, and additional information for evaluation.Conclusion: based on the information provided by the healthcare facility and without the return of the subject device, we are unable to confirm or determine the cause of the reported issue all rt329 infant continuous flow circuits are visually inspected, and pressure and flow tested during production, and those that fail are rejected.The subject breathing circuit would have met the required specifications at the time of production.The user instructions that accompany the rt329 infant continuous flow circuit show in pictorial format the correct set-up of the circuit and also states the following: - check that all connections, caps and/or plugs are tight before use.- visually inspect breathing sets for damage (e.G.Crushed tube or cracked connector) before use and replace if damaged.- perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient.- ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient.- appropriate patient monitoring (e.G.Oxygen saturation) must be used at all times.
Event or Problem Description
Fisher & paykel (f&p) healthcare was notified via an fda medwatch form that a healthcare facility in north carolina reported that the 'blue cap' of an rt329 infant continuous flow circuit dislodged causing a leak.The healthcare facility reported that as a result, the patient desaturated, and medical intervention was required.F&p healthcare have requested further information about the reported event, including information about the patient condition, sequence of events, and the reported fault with the subject rt329 infant continuous flow circuit.However, no further information has been provided.F&p healthcare will provide a follow up report upon completion of our investigation.

• 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: 20808360
• Report Number: 9611451-2024-00854
• Device Sequence Number: 18510234
• Product Code: BTT
• UDI-Device Identifier: 09420012431073
• UDI-Public: (01)09420012431073(10)2102633950(11)230530(17)280530
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K020332
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: RT329
• Device Catalogue Number: RT329
• Device Lot Number: 2102633950
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2024
• Supplement Date Received by Manufacturer: 01/14/2025
• Initial Report FDA Received Date: 11/28/2024
• Supplement Report FDA Received Date: 02/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/30/2023
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 4 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White