MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE, LTD. FP OPTIFLOW JUNIOR 2; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)

Model Number	OJR412
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Optiflow junior nasal cannula was in-place and delivering oxygen to the patient.Upon physical assessment, it was noted that the spring tubing had detached from the nose piece.There was no prior interaction with the nasal cannula that was identified as causing the detachment.

• Brand Name: FP OPTIFLOW JUNIOR 2
• Common Device Name: HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE, LTD.; 17400 laguna canyon road; suite 300; irvine CA 92618
• MDR Report Key: 25277195
• Report Number: 25277195
• Device Sequence Number: 9703284
• Product Code: BTT
• UDI-Device Identifier: 09420012435910
• UDI-Public: (01)09420012435910
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/07/2026
• Report Date (Section F): 05/07/2026

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
• Device Model Number: OJR412
• Device Catalogue Number: OJR412
• Device Lot Number: 2103816457
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/26/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/26/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 21 DA
• Patient Sex: Male
• Date Report Sent to FDA: 05/07/2026