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

Model Number BC161

Device Problems Unintended Movement (3026); Physical Resistance/Sticking (4012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are currently attempting to retrieve the complaint device for evaluation.We will provide a follow up report upon completion of our 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 not intact and moving.The bubble cpap generator is part of the bc161 bubble cpap system kit.There was no reported patient consequences.

Event Description

A healthcare facility in ohio reported via a fisher & paykel healthcare (f&p) field representative that the cpap probe of a bubble cpap generator was not intact and moving.The bubble cpap generator is part of the bc161 bubble cpap system kit.There was no reported patient consequences.

Manufacturer Narrative

(b)(4).Method: the complaint bc161-10 bubble cpap system was received at fisher & paykel healthcare in new zealand for investigation and was visually inspected.The dimensions of the lid and probe of the bubble cpap system were measured.Results: no physical damage was observed to the returned bubble cpap generator and probe.The dimension of the probe was within the drawing specification; however, it was observed that the dimension of the lid of the complaint bubble cpap generator was out of specification.A lot check was not performed as lot information was not provided.Conclusion: based on the investigation conducted, it is likely that the reported fault was due to the wider distance between the probe connection on the lid.The existing design of the cpap probe is intended to be adjustable.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: BZD
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 9222097
• MDR Text Key: 177825761
• Report Number: 9611451-2019-01007
• Device Sequence Number: 1
• Product Code: BZD
• 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,health
• Type of Report: Initial,Followup
• Report Date: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BC161
• Device Catalogue Number: BC161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2019
• Date Manufacturer Received: 03/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1