MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD 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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Section d4: serial number intentionally left blank as the information is not applicable to the subject device.Section d4: the device details of two suspect units were provided as the healthcare facility was unable to confirm which was the complaint unit.The device details for the additional udi device is listed: lot#: 2102574005; date of manufacture: 05 apr 2023.Method: the complaint bc161 bubble cpap system was not returned to fisher & paykel healthcare (f&p) for evaluation as it was discarded by the healthcare facility following the reported event.Our investigation is based on the information provided by the healthcare facility, previous investigations of similar complaints, and our knowledge of the product.Results: the healthcare facility stated that the probe of the bc161 bubble cpap system was not staying in place during patient use.It was reported that the cpap probe was set to 5 and the gauge would be found slipped at 6.The healthcare facility confirmed that there was no patient harm.Conclusion: without the return of the complaint device, our investigation was unable to determine the exact cause of the reported damage.The existing design of the cpap probe is intended to be adjustable, which leads to the possibility of inadertent movement.We note that there is a physical stop in the bubble cpap probe, to prevent the pressure from exceeding 10cmh2o, and that a pressure manifold is used with the breathing circuit, to reduce the risk of unsafe circuit pressure.All bc161 bubble cpap system are visually inspected, and pressure tested before leaving the production line, those that fail are rejected.Our user instructions which accompany the bc161 bubble cpap system state: - "always use pressure monitoring to verify that the patient is receiving the prescribed cpap level." - "ensure that the humidifier and bubble cpap generator are mounted below the patient." - "regularly observe the cpap generator for bubbling.If bubbling is not observed, check for and minimize air leaks in the system and at the patient.".
Event or Problem Description
A healthcare facility in texas reported via a fisher & paykel healthcare (f&p) field representative that the peep gauge of the bc161 bubble cpap system was not staying in place during patient use.There was no 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: 20315753
• Report Number: 9611451-2024-00692
• Device Sequence Number: 7613273
• Product Code: BZD
• UDI-Device Identifier: 09420012414953
• UDI-Public: (01)09420012414953(10)2102812269(11)231002(17)261002
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/29/2024

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 Expiration Date: 10/02/2026
• Device Model Number: BC161-10
• Device Catalogue Number: BC161-10
• Device Lot Number: 2102812269
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/29/2024
• Initial Report FDA Received Date: 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/02/2023
• 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