MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD ADULT INSPIRATORY HEATED BREATHING CIRCUIT; BTT

Model Number	RT202
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complaint rt202 adult inspiratory heated breathing circuits are currently en route to fisher & paykel healthcare (f&p) 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 the united kingdom reported via a fisher & paykel healthcare (f&p) field representative, that eleven rt202 adult inspiratory heated breathing circuits were found leaking from the connection of inspiratory chamber port.There was no reported patient involvement.
Additional Manufacturer Narrative
(b)(4).Method: the complaint rt202 adult inspiratory heated breathing circuits were returned to fisher & paykel healthcare (f&p) in new zealand, where they were visually inspected and leakage tested.Results: visual inspection of the returned rt202 adult inspiratory heated breathing circuits revealed no physical damage observed.The leakage test also revealed that the breathing circuits were within specification.Conclusion: we were unable to determine what may have caused the leakage as reported by the customer, as no fault was found with the returned devices.All rt202 adult inspiratory heated breathing circuits are visually inspected, and pressure and flow tested during production, and those that fail are rejected.The subject breathing circuits would have met the required specifications at the time of production.Our user instructions that accompany the rt202 adult inspiratory heated breathing circuits state the following: - "check all connections are tight before use." - "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.".
Event or Problem Description
A healthcare facility in the united kingdom reported via a fisher & paykel healthcare (f&p) field representative, that eleven rt202 adult inspiratory heated breathing circuits were found leaking from the connection of inspiratory chamber port.There was no reported patient involvement.

• Brand Name: ADULT INSPIRATORY HEATED BREATHING CIRCUIT
• Common Device Name: BTT
• 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: omid taheri ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 8007923912
• MDR Report Key: 17339745
• Report Number: 9611451-2023-00664
• Device Sequence Number: 6903400
• Product Code: BTT
• UDI-Device Identifier: 09420012430304
• UDI-Public: (01)09420012430304(10)2102379517(11)221015
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2023

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: RT202
• Device Catalogue Number: RT202
• Device Lot Number: 2102379517
• 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: 07/13/2023
• Supplement Date Received by Manufacturer: 11/09/2023
• Initial Report FDA Received Date: 07/17/2023
• Supplement Report FDA Received Date: 11/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2022
• 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