MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD ADULT TRACHE DIRECT INTERFACE; BZA

Model Number OPT970

Device Problem Disconnection (1171)

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

Event Date 08/09/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The opt970 interface is used to deliver humidified oxygen to patients via tracheostomy.The interface is held in place by a neck strap and also includes a lanyard which is placed around the patient's neck or attached to the patient's clothing or bedding to remove the load of the breathing circuit from the patient's trache.We followed up with the hospital to sought further information.We were informed that the spo2 of the patient was 98% at the time of the incident and there was no patient injury.Method: the complaint opt970 or the 900pt551 breathing circuit were not returned to fisher & paykel healthcare in (b)(4).Our investigation is based on our knowledge of the product and information provided by the hospital.Results: we were unable to determine the cause of the reported fault.The customer was able to reconnect the circuit and continue the therapy indicates that there was no fault with the complaint device.It is possible that the device was accidentally pulled or the patient was trying to remove the device.Conclusion: the airvo 2 humidifier is designed to deliver humidified high flow therapy which by its nature is an open, non-sealed system.This is quite different to a closed pressure therapy such as non invasive or invasive ventilation.Therefore, the delivered flow is higher than the peak inspiration demand resulting in surplus flow.For a leak to be detected, it must be of a magnitude greater than the normal use, such as completely removing the chamber from the heater plate.The airvo 2 user manual warns the user that: appropriate patient monitoring must be used at all times.The unit is not intended for life support.Our user instructions that accompany the opt970 trache interface state: to ensure loading and movement on tracheostomy tube is kept to a minimum, make sure the lanyard is secured appropriately.Do not crush or stretch tube, to prevent loss of therapy.Appropriate patient monitoring must be used at all times.

Event Description

A hospital in (b)(6) reported via a fisher & paykel healthcare (f&p) representative that during a routine check of a tracheostomy patient, they noticed the 900pt551 breathing circuit was disconnected from the opt970 tracheostomy interface and the airvo 2 unit was not alarming.The circuit and interface was reconnected by the staff.There were no patient consequences reported.

• Brand Name: ADULT TRACHE DIRECT INTERFACE
• Type of Device: BZA
• 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 ; 9194534000
• MDR Report Key: 7858343
• MDR Text Key: 119663956
• Report Number: 9611451-2018-00773
• Device Sequence Number: 1
• Product Code: BZA
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OPT970
• Device Catalogue Number: OPT970
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2018
• 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