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

Model Number BC161

Device Problem Pressure Problem (3012)

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

Event Date 09/13/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the complaint bc100 bubble cpap generator was returned to fph in (b)(4) and was visually inspected.The dimensions of the lid and the probe of the bc100 bubble cpap generator were measured.Two samples of lids were taken from the production line and their dimensions were also measured and compared to the dimension of the lid of the complaint bubble cpap generator.Results: no physical damage was observed to the returned bubble cpap generator.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.No fault was found to the sample lids that were taken from the production line.Their dimensions were all within specification.A lot check was not performed as lot information was not provided.Conclusion: based on the inspection conducted, it is likely that the reported fault was due to the wider distance between the probe connection.No patient consequence was reported as a result of this incident.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 pediatric 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." this is the only complaint of this nature that we received in the last 12 months to the end of (b)(6) 2015.

Event Description

A hospital in (b)(6) reported to a fisher & paykel healthcare (fph) field representative that the bubble cpap probe of a bc100 bubble cpap generator, which is part of the bc161 bubble cpap system kit, "was set to 7cm h2o but found shortly after to have dropped to 10cm h2o".It was also reported that the cpap probe was not holding its pressure and was slipping while being use on a patient.No patient consequence was reported.

• Brand Name: BUBBLE CPAP SYSTEM KIT
• Type of Device: BTT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, auckland 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, auckland 2013 ; NZ 2013
• Manufacturer Contact: raymond yan ; 15365 barranca parkway; irvine; 9494534000
• MDR Report Key: 5129275
• MDR Text Key: 27699639
• Report Number: 9611451-2015-00428
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K100011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Report Date: 09/14/2015

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: BC161
• Device Catalogue Number: BC161
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/05/2015
• 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