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

Model Number BC153-10

Device Problems Device Slipped (1584); Device Issue (2379)

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

Event Date 10/27/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Our investigation is currently in progress.We will provide a follow up report upon completion of our investigation.

Event Description

A healthcare facility in (b)(6), reported to a fisher & paykel healthcare (fph) representative that the bubble cpap probe of a bubble cpap generator which is part of the bc163 bubble cpap system kit was set to 5 cmh2o but after 20 minutes was at 8 cmh2o.They further reported that the probe was sliding more freely.No patient consequence was reported.

Manufacturer Narrative

(b)(4).Method: the complaint device was not returned to fisher & paykel healthcare for investigation.The customer disposed of the complaint device before they could be requested for investigation.Therefore, our investigation is based on the information provided by the customer, previous similar investigations and our knowledge of the product.Results: the customer reported that the bubble cpap probe was sliding more freely.Conclusion: without the return of the complaint device we are unable to determine what may have caused the problem reported by the customer.If the complaint device was returned it would have been visually inspected and the dimensions of the bubble cpap probe and lid of the bubble cpap generator would have been checked against the specification.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 healthcare facility in (b)(6), reported to a fisher & paykel healthcare (fph) representative that the bubble cpap probe of a bubble cpap generator which is part of the bc163 bubble cpap system kit was set to 5 cmh2o but after 20 minutes was at 8 cmh2o.They further reported that the probe was sliding more freely.Additional information received from the healthcare facility revealed that the complaint device was a bc153 bubble cpap system kit.No patient consequence was reported.

• 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: raymond yan ; 15365 barranca parkway; irvine, CA 92618-2216 ; 9494534000
• MDR Report Key: 5252505
• MDR Text Key: 32357696
• Report Number: 9611451-2015-00501
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/27/2015

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: BC153-10
• Device Catalogue Number: BC153-10
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/27/2015
• Initial Date FDA Received: 11/26/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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