MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD TEMPERATURE PROBE

Model Number	900MR869
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6), the subject 900mr869 temperature/flow probe has been requested to be returned to fisher & paykel (f&p) healthcare in 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 a 900mr869 temperature/flow probe was identified to be easily dislodged from a temperature probe port of an rt265 infant dual-heated evaqua2 breathing circuit during setup and prior to patient use.There was no reported patient harm.

• Brand Name: TEMPERATURE PROBE
• Common Device Name: TEMPERATURE PROBE
• 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: 23752231
• Report Number: 9611451-2025-01794
• Device Sequence Number: 5892265
• Product Code: BTT
• UDI-Device Identifier: 09420012401311
• UDI-Public: (01)09420012401311(10)2103213870(11)240701
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K983112
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2026

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: 900MR869
• Device Catalogue Number: 900MR869
• Device Lot Number: 2103213870
• 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: 11/25/2025
• Supplement Date Received by Manufacturer: 03/29/2026
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2024
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: F&P RT265 INFANT EVAQUA2 BREATHING CIRCUIT
• Patient Sex: Unknown