MAUDE Adverse Event Report: BUBBLE CPAP SYSTEM; BTT

Model Number BC161-10

Device Problems Loose or Intermittent Connection (1371); Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are currently in the process of finalising our investigation.We will provide a follow up report upon completion of investigation.

Event Description

A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that the cpap probe of a bubble cpap generator was loose.The bubble cpap generator is part of the bc161-10 bubble cpap system kit.There was no patient involvement.

Event Description

A healthcare facility in new jersey reported via a fisher & paykel healthacre (f&p) field representative that the cpap probe of a bubble cpap generator was loose.The bubble cpap generator is part of the bc161-10 bubble cpap system kit.There was no patient involvement.

Manufacturer Narrative

(b)(4).Method: the complaint bc161-10 bubble cpap system was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is based on the information provided by the customer, previous investigations of similar complaints, and our knowledge of the product.Results: the customer reported that the cpap probe of a bubble cpap generator was loose.Conclusion: without the return of the complaint device, we were unable to determine what may have caused the reported failure.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.".

• Brand Name: BUBBLE CPAP SYSTEM
• Type of Device: BTT
• MDR Report Key: 11369055
• MDR Text Key: 234446121
• Report Number: 9611451-2021-00208
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• PMA/PMN Number: K100011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BC161-10
• Device Catalogue Number: BC161-10
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1