MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LIMITED ADULT HEATED WALL REUSABLE BREATHING CIRCUIT; BTT

Model Number	900MR810
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare facility in taiwan reported, via a fisher & paykel healthcare (f&p) field representative, that fifteen 900mr810 adult heated wall reusable breathing circuit's were damaged.There was no patient involvement as the issue was found whilst the circuit was not in use on a patient.
Additional Manufacturer Narrative
(b)(4).Fisher & paykel healthcare (f&p) is 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 900mr810 adult heated wall reusable breathing circuit's were received at fisher & paykel healthcare (f&p) new zealand, where they were visually inspected and fault replication was attempted.Results: visual inspection of the complaint circuits confirmed that helix delamination had occurred near the chamber end cuff.Two of the fifteen circuits also had helix delamination near the patient end cuff.Two tests were run to attempt to replicate the helix delamination.First, a temperature test was run to determine if the use of pasteurization to clean the circuits could have caused the reported damage.A sample 900mr810 adult heated wall reusable breathing circuit was soaked in water at 90°c overnight to simulate pasteurization.This test did not replicate the reported event.Second, two 900mr810 adult heated wall reusable breathing circuit samples were intentionally pulled and twisted to simulate harsh handling.This test did not replicate the reported event.Conclusion: we are unable to determine the cause of the reported event.However, it is most likely caused by physical damage due to impact during transportation of the device.All 900mr810 adult heated wall reusable breathing circuits are visually inspected and pressure tested prior to being released for distribution.Any circuits that fail are rejected.This suggests the reported damaged occurred after the subject breathing circuit was released for distribution.The user instructions that accompany the 900mr810 adult heated wall reusable breathing circuit state the following: inspect circuit before re-use, do not use if the circuit shows signs of deterioration, such as cracks, tears, or damage"."perform a pressure and leak test on the breathing system, and check for occlusions, before connecting to a patient"."do not cover the circuit with materials such as blankets, towels or bed linen"."disconnect tube by handling end connectors only, do not pull or twist tubing, as this may cause damage".
Event or Problem Description
A healthcare facility in taiwan reported, via a fisher & paykel healthcare (f&p) field representative, that fifteen 900mr810 adult heated wall reusable breathing circuit's were damaged.There was no patient involvement as the issue was found whilst the circuit was not in use on a patient.

• Brand Name: ADULT HEATED WALL REUSABLE BREATHING CIRCUIT
• Common Device Name: BTT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: faranak gomarooni ; 17400 laguna canyon road; suite 300; irvine, CA 92618-2216 ; 9494534000
• MDR Report Key: 15965601
• Report Number: 9611451-2022-01155
• Device Sequence Number: 5107519
• Product Code: BTT
• UDI-Device Identifier: 09420012432247
• UDI-Public: (01)09420012432247(10)2102033904(11)220214
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K131957
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2022

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: 900MR810
• Device Catalogue Number: 900MR810
• Device Lot Number: 2102033904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2022
• Supplement Date Received by Manufacturer: 04/05/2023
• Initial Report FDA Received Date: 12/13/2022
• Supplement Report FDA Received Date: 05/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown