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

Model Number BC161-10

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Date 10/19/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint bc161-10 bubble cpap system is expected, but has not yet been returned to fisher & paykel healthcare for evaluation.We will provide a follow up report upon completion of our investigation.

Event Description

A hospital in (b)(6) reported via a fisher & paykel healthcare representative that the blue cap on the pressure relief manifold of the bc161-10 bubble cpap system was missing.There was no patient involvement.

Event Description

A hospital in australia reported via a fisher & paykel healthcare representative that the blue cap on the pressure relief manifold of the bc161-10 bubble cpap system was missing.There was no patient involvement.

Manufacturer Narrative

(b)(4).Method: the complaint bc161-10 bubble cpap system, including the inspiratory limb, expiratory limb, mr290 autofeed humidification chamber and pressure manifold, were returned to fisher & paykel healthcare in new zealand for evaluation.Results: the plastic bag was returned unsealed and the pressure manifold's oxygen monitoring port cap was missing.Conclusion: we were unable to conclude if the missing part was missed during assembly or if it went missing at the customer's facility as the package was returned unsealed.The pressure manifold is 100% pressure tested and pressure set at the assembly line and those that fail the pressure test are isolated.The pressure manifold would fail the pressure test if a port cap is missing.The user instructions that accompany the bc161 bubble cpap circuit kit state the following: ensure that any unused ports have their caps and/or plugs in place before use.Test circuit for occlusions and pressure leaks using the flow elbow provided before connection to the infant." the user instructions additionally instruct the user to test the circuit for occlusions and pressure leaks before connecting the system to the infant.

• 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
• MDR Report Key: 8099362
• MDR Text Key: 129436203
• Report Number: 9611451-2016-00994
• Device Sequence Number: 1
• Product Code: BTT
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 10/25/2018

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: BC161-10
• Device Catalogue Number: BC161-10
• Device Lot Number: 2100315265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2018
• Initial Date Manufacturer Received: 10/25/2018
• Initial Date FDA Received: 11/23/2018
• Supplement Dates Manufacturer Received: 01/07/2019
• Supplement Dates FDA Received: 02/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1