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

Model Number OPT870

Device Problem Gas/Air Leak (2946)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are currently in the process of obtaining further information to determine if our product caused or contributed to the reported event.We will provide a follow up report upon completion of our investigation.

Event Description

A distributor reported on behalf of a healthcare facility in (b)(4) via a fisher & paykel healthcare (f&p) field representative that an opt870 adult tracheostomy interface was leaking air during use.There was no reported patient consequence.

Manufacturer Narrative

(b)(4).The opt870 adult tracheostomy 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 tracheostomy tube.Method: the complaint opt870 interface was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is based on the information and photo provided by the customer and our knowledge of the product.Results: visual inspection of the provided photo revealed that the tubing of the opt870 was pulled apart near the circuit connector and stretched near the manifold.Conclusion: without the complaint device received in fisher & paykel healthcare new zealand, we were unable to conclusively determine the cause of the reported failure.However, the damage was most likely caused by an excessive pulling force being exerted on the tubing by the patient or the care person.All optiflow interfaces are inspected during production for visual defects including cracks, tears, inclusions, discolouration and deformation.Any product that fails the visual inspection is rejected.The subject device would have met the required specification at the time of production.The user instructions accompanying opt870 adult tracheostomy interface state the following: "to ensure loading on tracheostomy tube is kept to a minimum, make sure lanyard is fitted appropriately." "do not crush or stretch tube.".

Event Description

A distributor reported on behalf of a healthcare facility in china via a fisher & paykel healthcare (f&p) field representative that an opt870 adult tracheostomy interface was leaking air during use.There was no reported patient consequence.

• 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
• MDR Report Key: 9680403
• MDR Text Key: 182718870
• Report Number: 9611451-2020-00132
• Device Sequence Number: 1
• Product Code: BZA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OPT870
• Device Catalogue Number: OPT870
• Device Lot Number: 2100687129
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1