MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD OPTIFLOW + MASK INTERFACE ADAPTER; BTT

Model Number OPT980

Device Problems Disconnection (1171); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are currently in the process of completing our investigation.We will provide a follow up report upon completion of the investigation.

Event Description

A distributor in (b)(4) reported that the connector of an opt980e optiflow + mask interface adaptor disconnects from the airvo 2 heated breathing tube.There was no reported patient involvement.

Event Description

A distributor in canada reported that the connector of an opt980e optiflow + mask interface adapter disconnects from the airvo 2 heated breathing tube.There was no reported patient involvement.

Manufacturer Narrative

(b)(4).The opt980 optiflow + mask interface adapter is an interface used to deliver humidified oxygen to patients.The interface is held in place by a head strap and also includes a lanyard which is placed around the patient's neck or attached to the patient's clothing or bedding to support the weight of the circuit and prevent the cannula being dislodged.Method: the complaint opt980e optiflow + mask interface adapter was returned to fisher & paykel healthcare (f&p) new zealand for investigation, where it was visually inspected.Results: visual inspection of the returned cannula revealed that the tubing was detached from the swivel connector.It was further observed that the tubing was stretched at the manifold and connector end.Conclusion: we are unable to determine the cause of the reported damage to the subject opt980e optiflow + mask interface adapter.However, the damage observed was likely caused by the tubing being pulled.All optiflow interfaces are inspected during production for visual defects including cracks, tears, inclusions, discoloration and stretching or deformation.Any product that fails the visual inspection is rejected.The subject cannula would have met the specification at the time of production.The user instructions which accompany the opt980e optiflow + mask interface adapter show in pictorial format the correct placement and fitting of the cannula and also warn: "appropriate patient monitoring must be used at all times.Failure to monitor the patient may result in loss of therapy, serious injury or death." "do not crush or stretch tube, to prevent loss of therapy." "failure to use the set-up described above can compromise performance and affect patient safety.".

• Brand Name: OPTIFLOW + MASK INTERFACE ADAPTER
• Type of Device: BTT
• 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 92618 ; 9494534000
• MDR Report Key: 13049831
• MDR Text Key: 284449563
• Report Number: 9611451-2021-01457
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K162553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/26/2021

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: Lay User/Patient
• Device Model Number: OPT980
• Device Catalogue Number: OPT980
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/26/2021
• Initial Date FDA Received: 12/20/2021
• Supplement Dates Manufacturer Received: 02/04/2022
• Supplement Dates FDA Received: 03/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: F&P AIRVO 2 HEATED BREATHING TUBE.; F&P AIRVO 2 HEATED BREATHING TUBE.