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

Model Number	BC161-10
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) fisher & paykel (f&p) healthcare 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 georgia reported via a fisher & paykel healthcare (f&p) field representative that a temperature/flow probe was loose and "falling out" from the temperature probe port of a bc161-10 bubble cpap system before patient use.There was no reported patient consequence.
Additional Manufacturer Narrative
(b)(4) method: the subject devices and additional information about the reported event and setup were requested to be provided to fisher & paykel (f&p) healthcare new zealand for evaluation.In addition, a review of the manufacturing records for the reported bc161-10 bubble cpap system was completed.Results: the healthcare facility reported that the subject devices were not available for return to f&p healthcare for evaluation.A review of the manufacturing records of the lot batch of the bc161-10 bubble cpap system was performed.The devices in the manufacturing lot passed all the required quality control measures, confirming they were manufactured in accordance with specifications.Additionally, no non-conformances were noted during the manufacturing process of the subject lot.Conclusion: based on the information provided by the healthcare facility and review of the manufacturing records, and without the return of the subject device, we are unable to determine the cause of the reported issue.As part of design validation and verification activities, all f&p healthcare products are tested to ensure they meet documented product requirements and specifications.At the end of the final assembly process, all bc161-10 bubble cpap system circuits are 100% tested as follows: functional testing for leak visual inspections for any visible defects and contamination.The instructions for use accompanying the bc161-10 bubble cpap system show in pictorial format the correct set-up of the system and also state the following: check all connections are tight before use and after any adjustment.Use patient oxygen monitoring.Always use pressure monitoring to verify that the patient is receiving the prescribed cpap level.Test circuit for occlusions and pressure leaks using the flow elbow provided before connection to the infant.
Event or Problem Description
A healthcare facility in georgia reported via a fisher & paykel healthcare (f&p) field representative that a temperature/flow probe was loose and "falling out" from the temperature probe port of a bc161-10 bubble cpap system before patient use.There was no reported patient consequence.

• Brand Name: FISHER & PAYKEL HEALTHCARE
• Common Device Name: BUBBLE CPAP SYSTEM
• 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 ; 9494341005
• MDR Report Key: 23218949
• Report Number: 9611451-2025-00966
• Device Sequence Number: 8706832
• Product Code: BZD
• UDI-Device Identifier: 09420012412430
• UDI-Public: (01)09420012412430(10)2103717897(11)250409(17)280409
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2025

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: 2103717897
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2025
• Supplement Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 10/05/2025
• Supplement Report FDA Received Date: 11/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/09/2025
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TEMPERATURE PROBE (BRAND + MODEL NOT PROVIDED); TEMPERATURE PROBE (BRAND + MODEL NOT PROVIDED)
• Patient Sex: Unknown