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

Model Number	RT225
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).The subject rt225 infant bias flow breathing circuit has been requested to be returned to fisher & paykel healthcare in new zealand for evaluation.We will provide a follow up report upon completion of our investigation.
Event or Problem Description
A healthcare facility in china reported that the water trap of a rt225 infant bias flow breathing circuit was found damaged during patient use.There was no patient harm reported.
Event or Problem Description
A healthcare facility in china reported that the water trap of a rt225 infant bias flow breathing circuit was found damaged during patient use.There was no patient harm reported.
Additional Manufacturer Narrative
(b)(4).Method: the subject rt225 infant bias flow breathing circuit was not returned to fisher & paykel (f&p) healthcare new zealand for evaluation as the healthcare facility discarded the device.Our investigation is therefore based on the information and photographs provided by the healthcare facility, and our knowledge of the product.Results: review of the provided photographs confirmed that the spring of the water trap was detached from the shaft and became loose.There was no visible damage on the shaft based on the provided photograph.Conclusion: the subject device was requested for investigation, however the customer reported that it was not available for investigation.Without the return of the subject device, we are unable to determine the cause of the reported event.All rt225 infant bias flow breathing 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 rt225 infant bias flow breathing circuit show in pictorial format the correct set-up of the circuit and also states the following: - visually inspect breathing sets for damage (e.G.Crushed tube or cracked connector) before use and replace if damaged.- ensure appropriate ventilator and flow source alarms are set before connecting breathing set to patient.- check all connections are tight before use.

• 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 vargas banuelos ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494341005
• MDR Report Key: 22112106
• Report Number: 9611451-2025-00497
• Device Sequence Number: 7157214
• Product Code: BZE
• UDI-Device Identifier: 09420012431080
• UDI-Public: (01)09420012431080(10)2103009145(11)240226(17)290226
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K020332
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2025

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: RT225
• Device Catalogue Number: RT225
• Device Lot Number: 2103009145
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2025
• Supplement Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 05/30/2025
• Supplement Report FDA Received Date: 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/26/2024
• 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