MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD FISHER & PAYKEL HEALTHCARE; BREATHING CIRCUIT

Model Number	900MR810
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A distributor in california reported via a fisher & paykel healthcare (f&p) field representative that the 900mr810 adult heated wall reusable breathing circuit had melted.There was no patient involvement as the issue was found whilst the device was not in use on a patient.
Additional Manufacturer Narrative
(b)(4).Fisher and paykel healthcare (f&p) are currently in the process of obtaining further information regarding the reported event.We have also requested the return of the subject 900mr810 adult heated wall reusable breathing circuit to f&p new zealand for investigation.We will provide a follow up report upon completion of our investigation.
Additional Manufacturer Narrative
(b)(4).Method: the subject 900mr810 adult heated wall reusable breathing circuit was received at fisher & paykel healthcare (f&p) in new zealand for investigation, where it was visually inspected, and the customer also provided additional information relating to the reported event upon request.Our investigation is thus based on the evaluation of the subject device, the information provided by the distributor and our knowledge of the product.Results: the distributor reported that the 900mr810 adult heated wall reusable breathing circuit was melted.Visual inspection of the subject tubing showed damage in the middle of the tubing, and revealed that the film of the tubing also appeared to be stretched and torn.Conclusion: we are unable to determine the cause of the reported event.However, damage to the tubing may be caused by factors such as incorrect set-up or being covered with a material and/or being under compressive load for a considerable length of time.All 900mr810 adult heated wall reusable breathing circuits are visually inspected and tested prior to being released for distribution.Any circuits that fail are rejected.This suggests the reported damage occurred after the subject breathing circuit was released for distribution.The user instructions that accompany the 900mr810 adult heated wall reusable breathing circuits 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 connectrs only, do not pull or twist tubing, as this may cause damage.".
Event or Problem Description
A distributor in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that the 900mr810 adult heated wall reusable breathing circuit had melted.There was no patient involvement as the issue was found whilst the device was not in use on a patient.

• Brand Name: FISHER & PAYKEL HEALTHCARE
• Common Device Name: BREATHING CIRCUIT
• 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: diego banuelos ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494341005
• MDR Report Key: 21188189
• Report Number: 9611451-2025-00045
• Device Sequence Number: 8639478
• Product Code: BTT
• UDI-Device Identifier: 09420012432247
• UDI-Public: (01)09420012432247(10)2103210084(11)240627(17)290626
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K131957
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2024

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: 2103210084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2024
• Supplement Date Received by Manufacturer: 03/03/2025
• Initial Report FDA Received Date: 01/19/2025
• Supplement Report FDA Received Date: 03/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2024
• 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