MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD F&P 850; HUMIDIFICATION CHAMBER

Model Number	MR290VX
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The subject mr290vx vented autofeed humidification chamber has been requested to be returned to fisher & paykel (f&p) healthcare new zealand for evaluation.We will provide a follow up report upon completion of our investigation.
Event or Problem Description
A distributor reported on behalf of a healthcare facility in japan, via a fisher & paykel (f&p) healthcare field representative, that an mr290vx vented autofeed humidification chamber was found leaking water during patient use.There was no patient involvement.

• Brand Name: F&P 850
• 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: 24110751
• Report Number: 9611451-2026-00213
• Device Sequence Number: 21431067
• Product Code: BTT
• UDI-Device Identifier: 09420012401571
• UDI-Public: (01)09420012401571(10)2103826502(11)250626(17)300626
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2026

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: 2103826502
• 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: 12/26/2025
• Supplement Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 01/19/2026
• Supplement Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2025
• 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
• Patient Sex: Unknown