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

Model Number OPT970E

Device Problem Device Issue (2379)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The opt970e 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 trachea.The complaint opt970e was not returned to fph in (b)(6).Our investigation is accordingly based on the photograph of the subject device that was provided by the healthcare facility.Visual inspection of the photograph revealed that the tubing was disconnected from the manifold.The tubing was also observed to be stretched and partly torn where it had connected to the manifold.Based the photograph, the reported event mostly likely occurred as a result of excessive pulling force being exerted on the device.All optiflow interfaces are inspected during production for visual defects.Any product that fails the visual inspection is rejected.As the subject device had been in use for 2 weeks, this suggests that the reported damage occurred after release for distribution.Our user instructions that accompany the opt970e trachea interface state: to ensure loading and movement on tracheostomy tube is kept to a minimum, make sure the lanyard is secured appropriately.Do not crush or stretch tube, to prevent loss of therapy.Appropriate patient monitoring must be used at all times.

Event Description

A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (fph) field representative that the tubing of an opt970 tracheostomy interface had detached from the direct connection after 2 weeks of use.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: sharon kuruvilla ; 173 technology drive; suite100; irvine, CA 92618 ; 9194534000
• MDR Report Key: 6998455
• MDR Text Key: 91207174
• Report Number: 9611451-2017-01027
• Device Sequence Number: 1
• Product Code: BZA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: D069790
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Respiratory Therapist
• Type of Report: Initial
• Report Date: 10/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OPT970E
• Device Catalogue Number: OPT970E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/05/2017
• 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