MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LIMITED OPTIFLOW JUNIOR TUBING KIT; BTT

Model Number	RT330
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A distributor reported on behalf of a healthcare facility in japan, via a fisher and paykel healthcare (f&p) field representative, that the pressure relief valve of a rt330 optiflow junior tubing kit ws found leaking before patient use.There was no patient involvement.
Additional Manufacturer Narrative
(b)(4).The complaint rt330 optiflow junior tubing kit is currently en route to fisher & paykel healthcare (f&p) for evaluation.We will provide a follow-up report upon completion of our investigation.
Additional Manufacturer Narrative
(b)(4).Method: the complaint rt330 optiflow junior tubing kit was returned to fisher & paykel healthcare (f&p) in new zealand, where they were visually inspected and analyzed.Results: visual inspection of the complaint rt330 optiflow junior tubing kit revealed no damage was found to any part of the returned rt330 kit.The leak test also revealed that the breathing circuit was within specification.Performance testing conducted on the pressure relief manifold also showed that it operated as intended and no fault was found.Conclusion: we were unable to determine what may have caused the failed leak test as reported by the customer, as no fault was found with the returned device.All rt330 optiflow junior tubing kits 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.Our user instructions that accompany the rt330 optiflow junior tubing kit 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 reported on behalf of a healthcare facility in japan, via a fisher and paykel healthcare (f&p) field representative, that the pressure relief valve of a rt330 optiflow junior tubing kit was found leaking before patient use.There was no patient involvement.

• Brand Name: OPTIFLOW JUNIOR TUBING KIT
• Common Device Name: BTT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: faranak gomarooni ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494534000
• MDR Report Key: 16464826
• Report Number: 9611451-2023-00165
• Device Sequence Number: 14748092
• Product Code: BTT
• UDI-Device Identifier: 09420012431066
• UDI-Public: (01)09420012431066(10)2102319643(11)220825
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2023

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: RT330
• Device Catalogue Number: RT330
• Device Lot Number: 2102319643
• 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: 02/21/2023
• Supplement Date Received by Manufacturer: 06/20/2023
• Initial Report FDA Received Date: 03/01/2023
• Supplement Report FDA Received Date: 06/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: F&P MR850 RESPIRATORY HUMIDIFIER; F&P MR850 RESPIRATORY HUMIDIFIER; OA2015 BLENDER; OA2015 BLENDER
• Patient Sex: Unknown