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

Model Number	RT114
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A distributor in (b)(4) reported via a fisher & paykel healthcare (f&p) field representative, that two rt114 adult inspiratory heated breathing circuits failed the leak test before use.There was no patient involvement.
Additional Manufacturer Narrative
(b)(4).The complaint rt114 adult inspiratory heated breathing circuits are currently en route to fisher & paykel healthcare (f&p) for evaluation.We will provide a follow up report upon completion of investigation.
Additional Manufacturer Narrative
(b)(4).The complaint rt114 adult inspiratory heated breathing circuits are currently en route to fisher & paykel healthcare (f&p) for evaluation.We will provide a follow up report upon completion of investigation.
Event or Problem Description
A distributor in (b)(4) reported via a fisher & paykel healthcare (f&p) field representative, that two rt114 adult inspiratory heated breathing circuits failed the leak test before use.There was no patient involvement.
Additional Manufacturer Narrative
(b)(4).Method: the complaint rt114 adult inspiratory heated breathing circuits were returned to fisher & paykel healthcare (f&p) in new zealand, where they were visually inspected and pressure tested.Results: visual inspection of the complaint rt114 adult inspiratory heated breathing circuits revealed no damage found to any of the breathing circuits or the dryline.The pressure test also revealed that the breathing circuits were within specification.Conclusion: we were unable to determine what may have caused the failed leak test as reported by the customer, as no fault were found with the returned devices.All rt114 adult inspiratory heated breathing circuits are visually inspected, and pressure and flow tested during production, and those that fail are rejected.The subject adult breathing circuits would have met the required specifications at the time of production.Our user instructions that accompany the rt114 adult inspiratory heated breathing circuit 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 distributor in canada reported via a fisher & paykel healthcare (f&p) field representative, that two rt114 adult inspiratory heated breathing circuits failed the leak test before use.There was no 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: faranak gomarooni ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494534002
• MDR Report Key: 13237467
• Report Number: 9611451-2022-00018
• Device Sequence Number: 5947034
• Product Code: BTT
• UDI-Device Identifier: 09420012430397
• UDI-Public: (01)09420012430397(10)2100030765(11)160308
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2021

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: RT114
• Device Catalogue Number: RT114
• Device Lot Number: 2100030765
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2021
• Supplement Date Received by Manufacturer: 08/22/2022
• Initial Report FDA Received Date: 01/12/2022
• Supplement Report FDA Received Date: 08/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2016
• 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