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	10/23/2025
Type of Reportable Event	Malfunction
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 (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that the cpap probe of the bubble cpap generator slipped out of position.However, the unit was further inspected by the healthcare facility and no issues were identified with the device itself.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).Method: the bcpap generator (subject device), which is part of bc161-10, bubble cpap system kit (subject device) was returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is thus based on the evaluation of the returned device, information provided by the healthcare facility, and our knowledge of the product results: evaluation of the returned device revealed that the bcpap generator lid detent features were wider than the thickness of the bubble cpap probe.The bubble cpap probe was observed loose.Conclusion: based on the evaluation of the returned device, information provided by the healthcare facility and our knowledge of the product, the reported event resulted due to insufficient interaction between the bubble cpap probe and the bubble cpap lid.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 bc153 or bc163.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.".
Event or Problem Description
A healthcare facility in new jersey reported via a fisher & paykel healthcare (f&p) field representative that the cpap probe of the bubble cpap generator slipped out of position.However, the unit was further inspected by the healthcare facility and no issues were identified with the device itself.The bubble cpap generator is part of the bc161-10, bubble cpap system kit (subject device).There was no reported patient consequence.

• 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: 23613135
• Report Number: 9611451-2025-01574
• Device Sequence Number: 10072559
• Product Code: BZD
• UDI-Device Identifier: 09420012414953
• UDI-Public: (01)09420012414953(10)2103517633(11)241205(17)271205
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 01/28/2026

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: 2103517633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2025
• Supplement Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/05/2024
• 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