MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE, LTD. FLEXITRUNK; SET, TUBING AND SUPPORT, VENTILATOR (W HARNESS)

Model Number	BC191
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
While preparing to place the pt on nasal cpap the circuit would not pass leak test for circuit calibration.The problem was determined to be the trunk.We used two 70 mm trunks that both failed leak testing.Used a third 70 mm trunk from a different lot number and the leak test finally passed.Both failed trunks were from lot 2103966750.Health effect code: 4582.Device problem code: 1250.Reference report: mw5184622.

• Brand Name: FLEXITRUNK
• Common Device Name: SET, TUBING AND SUPPORT, VENTILATOR (W HARNESS)
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE, LTD.
• MDR Report Key: 24498476
• Report Number: MW5184623
• Device Sequence Number: 10115983
• Product Code: BZO
• UDI-Device Identifier: 09420012432469
• UDI-Public: (01)09420012432469
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/24/2026

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: BC191
• Device Lot Number: 2103966750
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/03/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 4 DA
• Patient Sex: Female
• Patient Weight: 2 KG
• Patient Race: White