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

Model Number BC161-10

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Low Oxygen Saturation (2477)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Further information was received from the hospital stating that no leak test was conducted on the subject bc161-10 bubble cpap system prior to patient use.Additionally, the customer stated that after the reported incident, the pressure manifold of the subject bubble cpap system was manipulated by the caregiver, thus the returned pressure manifold will not be in its original state.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 (b)(4) for evaluation.The components of the complaint bubble cpap system were visually inspected.The complaint pressure manifold was functionally tested in its returned state.The manifold cap of the pressure manifold was then adjusted to its preset flow rate and functionally tested.Results: no damage was found to the inspiratory limb, expiratory limb and mr290 chamber upon visual inspection.The pressure manifold's shroud clips were found to be broken and had evidence of manipulation by the customer.Functional testing of the complaint pressure manifold confirmed that it was out of specification.After adjustment of the pressure manifold to its preset flow rate, it was found to be within specification.Conclusion: we were unable to conclude what caused the failure as reported by the customer as the returned pressure manifold had been manipulated by the customer.All pressure relief manifolds are pressure tested prior to being released for distribution.Any manifolds that fail are rejected.This suggests that the subject pressure relief manifold was damaged after it was released for distribution.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.

Event Description

A hospital in (b)(6) reported via a fisher & paykel healthcare representative that the pressure manifold of the bc161-10 bubble cpap system would "pop off" at 3 cmh2o.The customer stated that "the baby was crashing" so they immediately removed the bubble cpap system and bagged the baby with a t-piece until a "babi" setup could be put together.The patient has since been reported to be in a stable condition.

• 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: 8044864
• MDR Text Key: 126346912
• Report Number: 9611451-2018-00941
• 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: 10/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BC161-10
• Device Catalogue Number: BC161-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/08/2018
• Initial Date FDA Received: 11/06/2018
• 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
• Patient Outcome(s): Required Intervention