MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD FISHER & PAYKEL HEALTHCARE; HUMIDIFICATION CHAMBER

Model Number	MR290VX
Medical Device Problem Codes	Crack (1135); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).The subject mr290v vented autofeed humidification chamber is currently en route to fisher & paykel healthcare 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 united kingdom reported that an mr290v humidification chamber was found leaking during patient use.There were no patient consequences reported.
Event or Problem Description
A healthcare facility in the united kingdom reported that an mr290v humidification chamber was found leaking during patient use.There were no patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Method: the subject mr290v vented autofeed humidification chamber was returned to fisher & paykel (f&p) healthcare in new zealand where it was visually inspected and analysed.Results: additional information provided by the healthcare facility indicated that their practice is to wipe the humidification chambers daily with cleaning wipes.Visual inspection of the returned mr290v vented autofeed humidification chamber confirmed the presence of a horizontal crack along the chamber base.Flange whitening was observed around the crack area.Smeared ink print was observed above the crack area.Material analysis identified that the humidification chamber was exposed to incompatible chemicals.Conclusion: the reported water leakage was confirmed to be due to a crack on the chamber dome.Based on our investigation, the crack is likely to have been caused by exposure to incompatible chemicals, resulting in environmental stress cracking of the chamber dome.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 mr290v vented autofeed humidification chamber state the following: - do not soak, wash or sterilize this product.Avoid contact with chemicals, cleaning agents, or hand sanitizers.- do not use the chamber if the seals are not intact when received, or if it has been dropped.- use of the mr290 above maximum operating pressure may lead to cracking, water leakage and, on rare occasions, could lead to a loss of ventilator pressure.- use usp sterile water for inhalation or equivalent for humidification.Do not add other substances to the water.- ensure appropriate ventilator or flow source alarms are set before connecting breathing sets to patient.

• Brand Name: FISHER & PAYKEL HEALTHCARE
• Common Device Name: HUMIDIFICATION CHAMBER
• 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: 21916017
• Report Number: 9611451-2025-00378
• Device Sequence Number: 9096384
• Product Code: BTT
• UDI-Device Identifier: 09420012401571
• UDI-Public: (01)09420012401571(10)2103311073(11)240828(17)290828
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K934140
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2025

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: MR290VX
• Device Catalogue Number: MR290VX
• Device Lot Number: 2103311073
• 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: 04/08/2025
• Supplement Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 04/27/2025
• Supplement Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2024
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BREATHING CIRCUIT: GETINGE BREATHING SYS 15MM KIT; BREATHING CIRCUIT: GETINGE BREATHING SYS 15MM KIT; RESPIRATORY HUMIDIFIER: F&P HEALTHCARE MR850; RESPIRATORY HUMIDIFIER: F&P HEALTHCARE MR850; VENTILATOR: GETINGE SERVO-N; VENTILATOR: GETINGE SERVO-N
• Patient Sex: Unknown