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

Model Number	RT125
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A distributor reported on behalf of a healthcare facility in thailand via a fisher and paykel healthcare (f&p) field representative, that the rt125 infant bias flow breathing circuit failed the ventilator leak test before use.There was no patient involvement.
Additional Manufacturer Narrative
(b)(4).We are currently in the process of completing our investigation.We will provide a follow up report upon completion of our investigation.
Additional Manufacturer Narrative
(b)(4).Method: the complaint rt125 infant bias flow breathing circuit was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is thus based on the information provided by the customer and our knowledge of the product.Results: the customer reported that the rt125 infant bias flow breathing circuit failed the ventilator leak test before use.Conclusion: without the complaint device, we are unable to determine what may have caused the reported event.All rt125 infant bias 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 rt125 infant bias flow breathing circuit show in pictorial format the correct set-up of the circuit and also states 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 thailand via a fisher and paykel healthcare (f&p) field representative, that the rt125 infant bias flow breathing circuit failed the ventilator leak test before use.There was no patient involvement.

• Brand Name: INFANT BIAS 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: 15705167
• Report Number: 9611451-2022-01023
• Device Sequence Number: 15108346
• Product Code: BTT
• UDI-Device Identifier: 09420012431141
• UDI-Public: (01)09420012431141(10)2102179960(11)220516
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2022

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: RT125
• Device Catalogue Number: RT125
• Device Lot Number: 2102179960
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2022
• Supplement Date Received by Manufacturer: 12/09/2022
• Initial Report FDA Received Date: 10/31/2022
• Supplement Report FDA Received Date: 12/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2022
• 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