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

Model Number	RT330
Medical Device Problem Codes	Crack (1135); Material Puncture/Hole (1504); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).The subject mr290v vented autofeed humidification chamber provided with the rt330 optiflow tubing kit has been requested to be returned to fisher & paykel healthcare in new zealand for evaluation.We will provide a follow up report upon completion of our investigation.
Event or Problem Description
A healthcare facility in the netherlands reported that an mr290v vented autofeed humidification chamber provided with an rt330 optiflow tubing kit had a 'tear' in the chamber.There was no patient harm reported.
Additional Manufacturer Narrative
(b)(4).Method: the subject mr290v vented autofeed humidification chamber provided with the rt330 optiflow tubing kit was returned to fisher & paykel (f&p) healthcare in new zealand where it was visually inspected and analysed.Results: visual inspection of the returned mr290v vented autofeed chamber identified a crack along the base of the chamber dome.Holes were also observed on the chamber's aluminum base.Further analysis identified evidence that the chamber had been exposed to an incompatible chemical.The healthcare facility reported that the chamber had been in contact with nebulised sodium chloride.Conclusion: the reported damage was confirmed.Based on our investigation, the crack is likely to be caused by exposure to an incompatible chemical, resulting in environmental stress cracking of the chamber dome.The damage to the base is due to the exposure of the chamber base to sodium chloride.Chlorine reacts with the heated aluminum base and readily corrodes the material over time, resulting in the holes observed.Every mr290v vented autofeed humidification chamber is pressure tested following the manufacturing process and any holes, cracks, or leaks would be identified during this process.In addition, the pressure test is followed by a visual inspection of each chamber.Any chamber which fails these tests is rejected.The subject mr290v vented autofeed humidification chamber would have met the required specifications at the time of production.The user instructions for the rt330 optiflow tubing kit state the following: use usp sterile water for inhalation or equivalent for humidification.Do not add other substances to the water.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.Do not soak, wash, sterilize, or reuse this product.Avoid contact with chemicals, cleaning agents, or hand sanitizers.Ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient.Ensure there is a water supply connected to the chamber and that water is present within the chamber.
Event or Problem Description
A healthcare facility in the netherlands reported that an mr290v vented autofeed humidification chamber provided with an rt330 optiflow tubing kit had a 'tear' in the chamber.There was no patient harm reported.

• 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: 21417661
• Report Number: 9611451-2025-00125
• Device Sequence Number: 9327573
• Product Code: BTT
• UDI-Device Identifier: 09420012431066
• UDI-Public: (01)09420012431066(10)2103290164(11)240813(17)290813
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2025

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: RT330
• Device Catalogue Number: RT330
• Device Lot Number: 2103290164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2025
• Supplement Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2024
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NEBULISED SODIUM CHLORIDE (NACL) 0.9%.
• Patient Sex: Unknown