MAUDE Adverse Event Report: ADULT TRACHE DIRECT INTERFACE; BZA

Model Number OPT870

Device Problems Break (1069); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are currently in progress of completing our investigation of the complaint opt870 adult tracheostomy interface.We will provide a follow-up report upon completion of our investigation.

Event Description

A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that the tubing of an opt870 adult tracheostomy interface had broke.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 provided by the customer, and our knowledge of the product.Results: the customer reported that the tubing of an opt870 adult tracheostomy interface had broke.The customer further reported that the device was used for 15 days.Conclusion: without the complaint device, we were unable to conclusively determine the cause of the reported failure.However, the damage was most likely due to using the complaint opt870 adult tracheostomy interface for more than the intended maximum use of 7 days.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." "this product is intended to be used for a maximum of 7 days" (hospital use).

Event Description

A healthcare facility in france reported via a fisher & paykel healthcare (f&p) field representative that the tubing of an opt870 adult tracheostomy interface had broke.There was no reported patient consequence.

• Brand Name: ADULT TRACHE DIRECT INTERFACE
• Type of Device: BZA
• MDR Report Key: 11600646
• MDR Text Key: 244409759
• Report Number: 9611451-2021-00369
• Device Sequence Number: 1
• Product Code: BZA
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2021
• 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: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2015
• 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