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

Model Number BC163-10

Device Problems Crack (1135); Unintended Movement (3026)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint bc163-10 bubble cpap system is currently en route to fisher and paykel healthcare (f&p) for investigation.We will provide a follow up report upon completion of our investigation.

Event Description

(b)(6) texas 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 bc163 bubble cpap system kit.There was no patient consequence.

Manufacturer Narrative

Ps418673.Method: the complaint (b)(4) bubble cpap system was returned to fisher & paykel healthcare (f&p) in new zealand for evaluation, where it was visually inspected by a trained f&p technician.Results: visual inspection revealed that the probe connector was cracked.Conclusion: 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 healthcare facility in texas 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 bc163 bubble cpap system kit.There was no 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: faranak gomarooni ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494534000
• MDR Report Key: 16717010
• MDR Text Key: 313642493
• Report Number: 9611451-2023-00232
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BC163-10
• Device Catalogue Number: BC163-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: F&P MR850 RESPIRATORY HUMIDIFIER.; F&P MR850 RESPIRATORY HUMIDIFIER.