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

Model Number BC161-10

Device Problem Unintended Movement (3026)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We have requested the return of the complaint bc163-10 bubble cpap system for investigation.We will provide a follow up report upon completion of our investigation.

Event Description

A distributor in india 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 bubble cpap system kit.There was no reported patient consequence.

Manufacturer Narrative

(b)(4).Method: the complaint bc161-10 bubble cpap systems were not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is based on the information and photography provided by the customer and knowledge of our product.Result: the customer reported that the cpap probe of a bubble cpap generator was loose.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 Description

A distributor in india 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 bubble cpap system kit.There was no reported patient consequence.

• Brand Name: BUBBLE CPAP SYSTEM
• Type of Device: BZD
• 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: omid taheri ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 8007923912
• MDR Report Key: 17159781
• MDR Text Key: 317860185
• Report Number: 9611451-2023-00563
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 09420012414953
• UDI-Public: (01)09420012414953(10)2102373457(11)221004
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K100011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2023
• 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: 2102373457
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2022
• 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