MAUDE Adverse Event Report: Fisher & Paykel Healthcare Ltd Fisher & Paykel Healthcare; Bubble CPAP Circuit Kits

Model Number	950N60J
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare facility in canada reported via a fisher & paykel healthcare (f&p) field representative that during demonstration, the cpap probe of the bubble cpap generator was found to be loose and sliding through the generator.The bubble cpap generator is part of the 950n60j, 950 neonatal bubble cpap dual heated circuit kit (subject device).There was no patient involvement.
Additional Manufacturer Narrative
(b)(6).Fisher & paykel healthcare (f&p) is currently in the process of completing our investigation.We will provide a follow up report upon completion of our investigation.

• Brand Name: Fisher & Paykel Healthcare
• Common Device Name: Bubble CPAP Circuit Kits
• 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 ; +1(949)434-1005
• MDR Report Key: 50942113
• Report Number: 9611451-2026-02851
• Device Sequence Number: 16137304
• Product Code: BZD
• UDI-Device Identifier: 09420012461179
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K221436
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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: 950N60J
• Device Catalogue Number: 950N60J
• Device Lot Number: 2103761854
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/09/2025
• 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