MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD INFANT LOW FLOW BREATHING CIRCUIT; BTT

Model Number	RT226
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complaint rt226 infant low flow breathing circuit is currently en route to fisher & paykel healthcare (f&p) for evaluation.We will provide a follow-up report upon completion of our investigation.
Event or Problem Description
A distributor reported on behalf of a healthcare facility in japan that a rt226 infant low flow breathing circuits failed the ventilator leak test before use.There was no patient involvement.
Additional Manufacturer Narrative
(b)(4).Method: the complaint rt226 infant low flow breathing circuit was returned to fisher & paykel healthcare (f&p) in new zealand, where it was visually inspected and leak tested.Results: visual inspection of the complaint rt226 infant low flow breathing circuit revealed no damage was found to any of the breathing circuits or the dryline.The leakage test also revealed that the breathing circuit was within specification.Conclusion: no fault was found with the returned device.The leakage experienced by the customer was most likely due to a loose connection in the setup.All rt226 infant low 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.Our user instructions that accompany the rt226 infant low flow 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 reported on behalf of a healthcare facility in japan that a rt226 infant low flow breathing circuit failed the ventilator leak test before use.There was no patient involvement.

• Brand Name: INFANT LOW FLOW 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 ; 9494534000
• MDR Report Key: 16576334
• Report Number: 9611451-2023-00219
• Device Sequence Number: 7180043
• Product Code: BTT
• UDI-Device Identifier: 09420012431165
• UDI-Public: (01)09420012431165(10)2102113512(11)220330
• 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,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: RT226
• Device Catalogue Number: RT226
• Device Lot Number: 2102113512
• 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: 06/18/2023
• Initial Report FDA Received Date: 03/20/2023
• Supplement Report FDA Received Date: 06/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2022
• 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