MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD INFANT SINGLE USE 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	12/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare facility in (b)(6) reported that a rt225 infant bias flow breathing circuit was leaking during use.There was no patient consequence.
Additional Manufacturer Narrative
(b)(4).Method: the complaint rt225 infant bias flow breathing circuit was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is thus based on the information and photographs provided by the customer, and our knowledge of the product.Results: visual inspection of the provided photographs revealed that the inspiratory tube of a rt225 infant bias flow breathing circuit had a hole.Conclusion: without the complaint device, we are unable to determine the cause of the reported event.All rt225 infant bias flow breathing circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.The subject infant breathing 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: "do not soak, wash, sterilize, or reuse this product.Avoid contact with chemicals, cleaning agents, or hand sanitizers." "perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient." "set appropriate ventilator alarms." "do not use beyond 7 days maximum duration of use.".

• Brand Name: INFANT SINGLE USE 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: faranak gomarooni ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494534000
• MDR Report Key: 14341818
• Report Number: 9611451-2022-00445
• Device Sequence Number: 17463977
• Product Code: BZE
• UDI-Device Identifier: 09420012431080
• UDI-Public: (01)09420012431080(10)2101298017(11)200917
• 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
• Report Date (Section B): 04/15/2022

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: RT225
• Device Catalogue Number: RT225
• Device Lot Number: 2101298017
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2022
• Initial Report FDA Received Date: 05/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2020
• 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