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

Model Number OPT870

Device Problem Device Handling Problem (3265)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The opt870 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.Method: fisher & paykel healthcare did not receive the complaint opt870 for evaluation, as it was discarded by the customer.Our investigation is based on the information provided by the customer.Results: the customer reported that the opt870 was torn at the tubing.It was further reported that the opt870 tubing was torn by the patient, who uses the opt870 tracheostomy interface at home.It was noted that the device kept getting caught between the customer's chair and the customer kept tugging on it.A lot check was not performed as no lot information was provided.Conclusion: we are unable to confirm the reported complaint, but based on the information provided by the customer, it is likely that the tubing became torn as a result of excessive pulling force being exerted on the device.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.Our user instructions that accompany the opt870 trache interface state: to ensure loading on tracheostomy tube is kept to a minimum, make sure lanyard is fitted appropriately.Do not crush or stretch tube.Device was discarded by the customer.

Event Description

A customer in the (b)(6) that an opt870 tracheostomy interface was torn at the corrugated tubing.It was further reported that the opt870 tubing was torn by the patient, who uses the opt870 tracheostomy interface at home.It was noted that the device kept getting caught between the customer's chair and the customer kept tugging on it.No patient consequence was 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: raymond yan ; 15365 barranca parkway; irvine, CA 92618-2216 ; 9194534000
• MDR Report Key: 6282018
• MDR Text Key: 65901289
• Report Number: 9611451-2017-00051
• Device Sequence Number: 1
• Product Code: BZA
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2017
• 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: 12/30/2016
• 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