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

Model Number BC163

Device Problem Unintended Movement (3026)

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

Event Date 11/09/2022

Event Type  malfunction  

Event Description

A healthcare facility in colorado reported, via a fisher & paykel healthcare (f&p) field representative, that the cpap probe of two bubble cpap generator's was loose.The bubble cpap generator is part of the bc163 bubble cpap system kit.There was no patient involvement as the issue was found whilst the device was not in use on a patient.

Manufacturer Narrative

(b)(4).The complaint bc163 bubble cpap system kit 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.

Manufacturer Narrative

(b)(4).Method: the complaint bc163-10 bubble cpap system was returned to fisher & paykel healthcare (f&p) in new zealand for evaluation, where it was visually inspected, and performance tested by a trained f&p technician.Results: the measured dimensions of the bc163-10 bubble cpap systems' generator was out of specification.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 colorado reported, via a fisher & paykel healthcare (f&p) field representative, that the cpap probe of two bubble cpap generator's was loose.The bubble cpap generator is part of the bc163 bubble cpap system kit.There was no patient involvement as the issue was found whilst the device was not in use on a patient.

• 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: 15927104
• MDR Text Key: 305069758
• Report Number: 9611451-2022-01116
• 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: User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 11/09/2022

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
• Device Operator: Health Professional
• Device Model Number: BC163
• Device Catalogue Number: BC163
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 11/09/2022
• Initial Date FDA Received: 12/06/2022
• Supplement Dates Manufacturer Received: 12/16/2022
• Supplement Dates FDA Received: 12/20/2022
• 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