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)
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare facility in alaska reported via a fisher & paykel healthcare (f&p) field representative that temperature/flow probes were "falling off" from a temperature probe port of a bc161-10 bubble cpap system.There was no reported patient consequence.
Additional Manufacturer Narrative
(b)(6).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 (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that temperature/flow probes were "falling off" from a temperature probe port of a bc161-10 bubble cpap system.There was no reported patient consequence.
Additional Manufacturer Narrative
(b)(6).Section d4: corrected udi and expiry date.Section h11: method: the subject devices and additional information about the reported event were requested to be provided to fisher & paykel (f&p) healthcare new zealand for evaluation.In addition, a review of the manufacturing records of the provided lot batch of the bc161-10 bubble cpap system was performed.Results: the healthcare facility was not able to provide additional information about the reported devices or event.However, the healthcare facility confirmed that no further events have occurred.A review of the manufacturing records of the lot batch of the bc161-10 bubble cpap system confirmed that the devices in the manufacturing lot passed all the required quality control measures, and were manufactured in accordance with specifications.Additionally, no non-conformances were noted during the manufacturing process of the subject lot.Conclusion: based on the limited information provided by the healthcare facility and without the return of the subject device, we are unable to confirm or determine the cause of the reported event.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.Resistance testing of the heater wire.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.

• 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: 22164756
• Report Number: 9611451-2025-00521
• Device Sequence Number: 7818723
• Product Code: BZD
• UDI-Device Identifier: 09420012412430
• UDI-Public: (01)09420012412430(10)2103360331(11)240918(17)270918
• Combination Product (Y/N): N
• Initial Reporter State: AK
• 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): 08/14/2025

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: 2103360331
• 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: 05/13/2025
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 06/08/2025
• Supplement Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/18/2024
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TEMPERATURE PROBE (BRAND + MODEL NOT PROVIDED).
• Patient Sex: Unknown