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

Model Number OPT970

Device Problems Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint opt970 tracheostomy interface is currently en route to fisher & paykel healthcare (b)(4) for evaluation.We will submit a follow up report upon completion of our investigation.

Event Description

A healthcare facility in (b)(6) reported that during set up of a opt970 tracheostomy interface, the interface tubing detached from the tracheostomy connector.There was no patient involvement.

Event Description

A healthcare facility in indiana reported that during set up of a opt970 tracheostomy interface, the interface tubing detached from the tracheostomy connector.There was no patient involvement.

Manufacturer Narrative

Ps299087 the opt970 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 toremove the load of the breathing circuit from the patient's trache.Method:the complaint opt970 interface was returned to fisher & paykel healthcare new zealand for investigation.Our assessment is based on visual inspection of the device and information provided by the customer.Results: visual inspection of the opt970 interface revealed that the inteface tubing was pulled apart and which disconnected tracheostomy connector from the tube.Conclusion: based on the information available we were unable to confirm the exact cause of the reported fault.However, based on previous investigations, it was mostly likely that the disconnection occurred as a result of pulling force being exerted on the device by the user.All optiflow interfaces are inspected during production for visual defects.Any product that fails the visual inspection is rejected.Our user instructions that accompany the opt970 tracheostomy 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.

• 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
• MDR Report Key: 8319010
• MDR Text Key: 137834300
• Report Number: 9611451-2019-00096
• Device Sequence Number: 1
• Product Code: BZA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 01/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OPT970
• Device Catalogue Number: OPT970
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2019
• Date Manufacturer Received: 02/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1