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

Model Number	RT202
Medical Device Problem Codes	Crack (1135); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Method: the subject mr290v vented autofeed humidification chamber and rt202 adult breathing circuit was returned to fisher & paykel (f&p) healthcare in new zealand for evaluation.Results: visual inspection identified a crack at the base of the dome of the chamber.Conclusion: our investigation identified a crack on the dome of the mr290v vented autofeed humidification chamber.Based on our investigation, the crack is likely to be due to externally applied mechanical stress.Every mr290v vented autofeed humidification chamber is pressure tested following the manufacturing process and any holes,cracks, or leaks would be identified during this process.In addition, the pressure test is followed by a visual inspection of each chamber.Any chamber which fails these tests is rejected.The subject mr290v vented autofeed humidification chambers would have met the required specifications at the time of production.The user instructions provided with the rt202 adult breathing circuit include 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.- perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient.
Event or Problem Description
A distributor reported on behalf of a healthcare facility in japan that an mr290v vented autofeed humidification chamber supplied with an rt202 adult breathing circuit was found leaking water during use.There was no patient harm reported.

• 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: 20298083
• Report Number: 9611451-2024-00518
• Device Sequence Number: 12699065
• Product Code: BTT
• UDI-Device Identifier: 09420012430304
• UDI-Public: (01)09420012430304(10)2103020732(11)240303(17)290303
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K983112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/28/2024

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
• Device Model Number: RT202
• Device Catalogue Number: RT202
• Device Lot Number: 2103020732
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2024
• Initial Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/03/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown