MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD NON-HEATED ADULT BREATHING CIRCUIT; BTT

Model Number	RT134
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A distributor reported on behalf of a healthcare facility in japan that a rt134 non-heated adult breathing circuit failed the ventilator pre-use test before use.There was no patient involvement.
Additional Manufacturer Narrative
(b)(4).The complaint rt134 non-heated adult breathing circuit is currently en route to fisher & paykel healthcare (f&p) for evaluation.We will provide a follow up report upon completion of investigation.
Additional Manufacturer Narrative
(b)(4), method: the complaint rt134 non-heated adult breathing circuit was returned to fisher & paykel healthcare in new zealand where it was visually inspected and leak tested.Results: leak testing found that the circuit was out of specification.The test revealed the location of the leak to be between the container and head assembly.Conclusion: we are unable to determine the cause of the reported event.The water trap of the breathing circuit consists of two parts, a lid and a bowl, which can be separated to allow the caregiver to empty the water trap.All breathing circuits are pressure tested for leaks during production and those that fail are rejected.This suggests that any leak must have developed after the breathing circuit was released for distribution, during transport, storage or use, possibly by distortion of the water trap when the bowl was connected.The user instructions that accompany the rt134 non-heated adult 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 rt134 non-heated adult breathing circuit failed the ventilator pre-use test before use.There was no patient involvement.

• Brand Name: NON-HEATED ADULT 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: omid taheri ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 8007923912
• MDR Report Key: 17044357
• Report Number: 9611451-2023-00483
• Device Sequence Number: 8577423
• Product Code: BTT
• UDI-Device Identifier: 09420012430533
• UDI-Public: (01)09420012430533(10)2101838862(11)211008
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K131895
• 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): 05/31/2023

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: RT134
• Device Catalogue Number: RT134
• Device Lot Number: 2101838862
• 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: 05/31/2023
• Supplement Date Received by Manufacturer: 09/14/2023
• Initial Report FDA Received Date: 06/01/2023
• Supplement Report FDA Received Date: 09/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2021
• 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: FUKUDA DENSHI SERVO VENTILATOR; FUKUDA DENSHI SERVO VENTILATOR
• Patient Sex: Unknown