MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD RESPIRATORY HUMIDIFIER; BTT

Model Number MR810

Device Problem Device Issue (2379)

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

Event Date 12/25/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the complaint mr810 humidifier was received at our fisher & paykel healthcare (fph) regional office in (b)(4), where it was inspected and performance tested by a trained fph technician.Our investigation is therefore based on the investigation conducted by the (b)(4) office and the information provided by the hospital.Result: the performance testing of the subject mr810 humidifier revealed that there were no faults with the humidifier.Conclusion: the mr810 has not caused or contributed to the event.The intersurgical mg5804855 circuit was used with the mr810 humidifier, and is not an approved fph product.The hospital confirmed that an unheated extension was used with the circuit.This would have likely been the reason for the excessive condensation reported by the customer.Our user instructions that accompany the mr810 respiratory humidifier states: the use of breathing circuits, chambers or other accessories which are not approved by fisher & paykel healthcare may impair performance or compromise safety.Condensate in the humidification system is an expected side effect of heated pass-over humidification systems in many conditions, and may vary between light misting to water droplets that form on the wall of cool breathing circuit tubing.The amount of condensate in the ventilation system is influenced by a number of multiple set up and environmental factors, including use of third party breathing circuits not approved by fph.The mr810 is equipped with several safety features that limit the risk of thermal injury.In the event of a failure the unit will shut down in a safe state and warn the user that a fault has occurred.It does this by monitoring the correct operation of its critical circuits.If a fault is detected it will try to report this by alarming visually.

Event Description

A hospital in (b)(6) reported that the mr810, trilogy100plus ventilator and an intersurgical circuit (mg5804855) were used on a patient.It was reported that the heater plate of the mr810 did not heat.Condensation entered the trachea of the patient and the patient's sp02 temporarily decreased.No patient consequence was reported.

• Brand Name: RESPIRATORY HUMIDIFIER
• 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; 2013 ; NZ 2013
• Manufacturer Contact: sharon kuruvilla ; 173 technology drive; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 7284841
• MDR Text Key: 100674281
• Report Number: 9611451-2018-00130
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012411914
• UDI-Public: 0109420012411914
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K033710
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/23/2018

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: Lay User/Patient
• Device Model Number: MR810
• Device Catalogue Number: MR810
• Device Lot Number: 150205
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/23/2018
• Initial Date FDA Received: 02/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1