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

Model Number	RT225
Medical Device Problem Codes	Leak/Splash (1354); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
A healthcare facility in china reported that a rt225 infant bias flow breathing circuit failed the ventilator leak test before patient use.There was no patient involvement.
Additional Manufacturer Narrative
(b)(4).Method: the complaint rt225 infant bias flow breathing circuit was returned to fisher & paykel healthcare (f&p) in new zealand for investigation, where it was visually inspected and leak tested.Results: visual inspection of the returned rt225 infant bias flow breathing circuit revealed no notable damage was observed on the returned parts.Further visual inspection found that the pressure port cap which was returned together with the circuit was a non fph part.Leak testing found that the circuit was out of specification.The test revealed that the leakage was at dry line pressure port.Conclusion: we are unable to determine the cause of the reported event.However, it is likely that the reported event occurred due to the use of a non fph part pressure port cap.All rt225 infant ventilator circuits are visually inspected, and pressure and flow tested during production, and those that fail are rejected.The subject infant circuit would have met the required specifications at the time of production our user instructions that accompany the rt225 infant bias flow breathing circuit state the following: - "the use of breathing circuits, chambers, accessories, or combinations which are not approved by fisher & paykel healthcare may result in poor humidification system performance, ventilator malfunction, and harm to the patient/ user".- "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." - "check all connections are tight before use.".
Event or Problem Description
A healthcare facility in china reported that a rt225 infant bias flow breathing circuit failed the ventilator leak test before patient use.There was no patient involvement.

• Brand Name: INFANT BIAS FLOW BREATHING CIRCUIT
• Common Device Name: BZE
• 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: 17339744
• Report Number: 9611451-2023-00662
• Device Sequence Number: 6903399
• Product Code: BZE
• UDI-Device Identifier: 09420012431080
• UDI-Public: (01)09420012431080(10)2102079360(11)220311
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2023

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: RT225
• Device Catalogue Number: RT225
• Device Lot Number: 2102079360
• 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: 07/12/2023
• Supplement Date Received by Manufacturer: 08/28/2023
• Initial Report FDA Received Date: 07/17/2023
• Supplement Report FDA Received Date: 08/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2022
• 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 Age: 1 DA
• Patient Sex: Female