MAUDE Adverse Event Report: BUBBLE CPAP SYSTEM; BTT

Model Number BC161-10

Device Problems Fluid/Blood Leak (1250); No Apparent Adverse Event (3189)

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

Event Type  malfunction  

Manufacturer Narrative

Ps340844.The complaint (b)(4) bubble cpap system is currently en route to fisher & paykel healthcare (b)(6) for evaluation.We will provide a follow up report upon completion of investigation.

Event Description

A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that the tubing of two bc161-10 bubble cpap system was found to be leaking.There was no reported patient consequence.

Manufacturer Narrative

(b)(4).Method: the complaint bc161-10 bubble cpap system respiratory tubings were not returned to fisher & paykel healthcare in new zealand for investigation.Our investigation is based on the information provided by the customer and our knowledge of the product.Conclusion: without the complaint device we are unable to confirm and determine the cause of the reported event.All flexitrunk nasal tubings are visually inspected and pressure tested before leaving the production line and those that fail are rejected.This suggests that any damage on the subject nasal tubing occurred after it was released for distribution.Our user instructions the accompany the flexitrunk infant nasal tubing state: "use caution when positioning the infant interface.Avoid excessive pull forces, sharp objects and tubing holders.Damage to the tubing may cause loss of pressure and require immediate replacement." a caution insert is included in the packaging to remind the user to take extra care when handling the flexitrunk.

Event Description

A healthcare facility in texas reported via a fisher & paykel healthacre (f&p) field representative that the tubing of two bc161-10 bubble cpap system was found to be leaking.There was no reported patient consequence.

• Brand Name: BUBBLE CPAP SYSTEM
• Type of Device: BTT
• MDR Report Key: 10172176
• MDR Text Key: 200274828
• Report Number: 9611451-2020-00555
• 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,health
• Type of Report: Initial,Followup
• Report Date: 05/20/2020

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: 2100695472
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/20/2020
• Initial Date FDA Received: 06/18/2020
• Supplement Dates Manufacturer Received: 08/28/2020
• Supplement Dates FDA Received: 09/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2019
• 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