MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LIMITED FISHER & PAYKEL HEALTHCARE; BUBBLE CPAP SYSTEM

Model Number	BC161-10
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare facility in texas reported via a fisher & paykel healthcare (f&p) field representative that the cpap probe of the three bubble cpap generators was slipping down out of position.The bubble cpap generator is part of the bc161-10, bubble cpap system kit (subject device).There was no reported patient consequence.
Additional Manufacturer Narrative
(b)(4) 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.
Event or Problem Description
A healthcare facility in texas reported via a fisher & paykel healthcare (f&p) field representative that the cpap probe of the three bubble cpap generators was slipping down out of position.The bubble cpap generator is part of the bc161-10, bubble cpap system kit (subject device).There was no reported patient consequence.
Additional Manufacturer Narrative
(b)(6).Method: the subject devices, three bc161-10 bubble cpap system kits were not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is thus based on the information provided by the healthcare facility, and our knowledge of the product.Results: the healthcare facility reported that the cpap probes of three bubble cpap generators slipped to the incorrect pressure.There was no reported patient consequence.Conclusion: without the subject devices being returned for investigation, we are unable to determine the cause of the reported event.The bubble cpap system delivers a humidified mixture of air and oxygen to the patient interface.Positive pressure is generated via an underwater seal in the bubble cpap generator, which creates a bubbling effect as gas exits the breathing circuit.The bubble cpap generator includes a mechanism for adjusting the depth of the gas exit to allow for the delivery of cpap levels ranging from 3 to 10 cm h2o.The adjustment mechanism is comprised of the bubble cpap probe and bubble cpap generator, and it also includes a physical stop to ensure that pressure does not exceed 10cmh2o.This means that the pressure received by the patient remains within a therapeutic range used to treat neonates and infants with cpap therapy.The user instructions that accompany the subject device illustrate in pictorial format the correct set-up and proper use of the bubble cpap system kit.The user instructions also state the following: - "always use pressure monitoring to verify that the patient is receiving the prescribed cpap level." - "do not use if product or packaging is damaged." - "do not reuse any part of the bc151 or bc161.It is manufactured for single patient use only.Reuse may result in transmission of infectious substances, interruption to treatment, serious harm or death." - "this product is intended to be used for a maximum of 7 days.".

• Brand Name: FISHER & PAYKEL HEALTHCARE
• Common Device Name: BUBBLE CPAP SYSTEM
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, auckland 2013 ; NZ 2013
• Manufacturer Contact: diego vargas banuelos ; 17400, laguna canyon road; suite 300; irvine, CA 92618 ; 9494341005
• MDR Report Key: 23489973
• Report Number: 9611451-2025-01324
• Device Sequence Number: 4758327
• Product Code: BZD
• UDI-Device Identifier: 09420012414953
• UDI-Public: (01)09420012414953(10)2103722098(11)250411(17)280411
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K100011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2026

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: BC161-10
• Device Catalogue Number: BC161-10
• Device Lot Number: 2103722098
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2025
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 11/06/2025
• Supplement Report FDA Received Date: 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/11/2025
• 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