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

Model Number	BC151-10
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that a cpap probe of a bubble cpap generator was not intact and moving.The bubble cpap generator is part of the bc151-10 bubble cpap system kit.There was no reported patient consequence.
Additional Manufacturer Narrative
(b)(4).We are currently in the process of completing our investigation.We will provide a follow up report upon completion of investigation.
Additional Manufacturer Narrative
(b)(4).Method: the complaint bc151-10 bubble cpap systems were not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is based on the information provided by the customer and knowledge of our product.Result: the customer reported that the cpap probe of the bubble cpap generator was not intact and moving.Conclusion: without the complaint device, we are unable to determine the cause of the reported fault.The existing design of the cpap probe is intended to be adjustable, which leads to the possibility of inadvertent movement.We note that there is a physical stop in the bubble cpap probe, to prevent the pressure from exceeding 10cmh20, and that a pressure manifold is used with the breathing circuit, to reduce the risk of unsafe circuit pressure.The user instructions that accompany the bubble cpap system kit illustrate in pictorial format the correct set-up and proper use of the bubble cpap generator.It also states the following: "always use pressure monitoring to verify that the patient is receiving the prescribed cpap level." "regularly observe the cpap generator for bubbling.If bubbling is not observed, check for and minimize the air leaks in the system and at the patient.If air leaks have been minimized, air flow may be increased to achieve continuous bubbling.".
Event or Problem Description
A healthcare facility in texas reported via a fisher & paykel healthcare (f&p) field representative that a cpap probe of a bubble cpap generator was not intact and moving.The bubble cpap generator is part of the bc151-10 bubble cpap system kit.There was no reported patient consequence.

• Brand Name: BUBBLE CPAP SYSTEM
• Common Device Name: BTT
• 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, 2013 ; NZ 2013
• Manufacturer Contact: faranak gomarooni ; 17400, laguna canyon road; suite 300; irvine, CA 92618 ; 9494534002
• MDR Report Key: 16383527
• Report Number: 9611451-2023-00110
• Device Sequence Number: 17547341
• Product Code: BTT
• UDI-Device Identifier: 09420012414939
• UDI-Public: (01)09420012414939(10)2102099157(11)220323
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2023

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: BC151-10
• Device Catalogue Number: BC151-10
• Device Lot Number: 2102099157
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2023
• Supplement Date Received by Manufacturer: 03/10/2023
• Initial Report FDA Received Date: 02/15/2023
• Supplement Report FDA Received Date: 03/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2022
• 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