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).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 a small round hole in the opt870 tube.The hole was located about half way between the interface and the connector.Conclusion: without the complaint device received in fisher & paykel healthcare (b)(4), we were unable to conclusively determine the cause of the reported failure.However, the damage was most likely caused by tubing being punctured with a round object.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 another distributor in (b)(6) via a fisher & paykel healthcare (f&p) field representative that an opt870 adult tracheostomy interface was leaking air during use.It was also reported that there were some holes on the tube.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
• 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 ; 4534000142
• MDR Report Key: 10084576
• MDR Text Key: 199530072
• Report Number: 9611451-2020-00496
• Device Sequence Number: 1
• Product Code: BZA
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 04/23/2020

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: Health Professional
• Device Model Number: OPT870
• Device Catalogue Number: OPT870
• Device Lot Number: 2100872776
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/23/2020
• Initial Date FDA Received: 05/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2019
• 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