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

Model Number BC151-10

Device Problem Device Slipped (1584)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Method: the two complaint bc100 bubble cpap generators and cpap probes were returned to fisher & paykel healthcare in (b)(4) for investigation and were visually inspected.The dimensions of the lid and probe of each bubble cpap were measured.Results: no physical damage was observed to the returned bubble cpap generators and probes.The dimensions of both probes were within the drawing specification; however, it was observed that the dimension of the lids of both bubble cpap generators were out of specification.Conclusion: based on the inspection conducted, it is likely that the reported fault was due to the wider distance between the probe connection on the lid in each complaint device.The existing design of the cpap probe is intended to be adjustable, which leads to the possibility of inadvertent movement.This risk has been considered in our hazard analysis and deemed to be acceptable due to the provision of a physical stop in the bubble cpap probe, to prevent the pressure from exceeding 10cmh20, and the use of a pressure manifold with the breathing circuit, to reduce the risk of unsafe circuit pressure.The bubble cpap system is for use in the hospital clinic environment such as the neonatal intensive care unit (nicu) and paediatric intensive care unit (picu).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 hospital in (b)(6) reported via a fisher & paykel healthcare representative that the probe of two bc151-10 bubble cpap delivery systems was slipping during use.It was reported that on two instances the peep slid from 5cmh2o to 7cmh2o.There was no patient consequence.

• Brand Name: BUBBLE CPAP SYSTEM
• Type of Device: BTT
• 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 ; 173 technology drive; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 7998151
• MDR Text Key: 124987353
• Report Number: 9611451-2018-00910
• Device Sequence Number: 1
• Product Code: BTT
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/24/2018

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: BC151-10
• Device Catalogue Number: BC151-10
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/24/2018
• Initial Date FDA Received: 10/23/2018
• 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