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

Model Number	OPT870
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ps339988.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 thus based on the information and photo provided by the customer, and our knowledge of the product.Results: visual inspection of the provided revealed a hole in the opt870 tube.Conclusion: without the complaint device, 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 blunt 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 or Problem Description
A distributor in (b)(6) reported on behalf of a healthcare facility, via a fisher & paykel healthcare (f&p) field representative, that the tubing of a 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
• Common Device Name: BZA
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 10121850
• Report Number: 9611451-2020-00515
• Device Sequence Number: 2851172
• Product Code: BZA
• UDI-Device Identifier: 09420012432148
• UDI-Public: 010942001243214810
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 05/08/2020

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
• Operator of Device: Health Professional
• Device Model Number: OPT870
• Device Catalogue Number: OPT870
• Device Lot Number: 2100749259
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2020
• Initial Report FDA Received Date: 06/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1