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

Model Number OPT980E

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint opt980e optiflow + mask interface adapter is currently en route to fisher & paykel healthcare (f&p) for evaluation.We will provide a follow up report upon completion of investigation.

Event Description

A distributor in (b)(4) reported via a fisher & paykel healthcare (f&p) field representative that the tubing of an opt980e optiflow + mask interface adapter was found damaged during patient use.There were no reported patient consequences.

Event Description

A distributor in canada reported via a fisher & paykel healthcare (f&p) field representative that the tubing of an opt980e optiflow + mask interface adapter was found damaged during patient use.There were no reported patient consequences.

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.Our investigation is based on the evaluation of the complaint cannula, the information provided by the customer, and our knowledge of the product.Results: visual inspection of the returned cannula revealed that the tubing was detached from the 3-way connector.It was further observed that the tubing was stretched in several areas, including the end that was detached from the 3-way connector.It was additionally reported by the customer that the lanyard was not used to secure the cannula.Conclusion: we are unable to determine the cause of the reported damage to the subject opt980e optiflow + mask interface adapter.However, based on our knowledge of the product and our observation that parts of the tubing appeared to have been stretched, the reported damage is likely to have been caused by the tubing being subjected to excessive force during use.It should be noted that the lanyard was not used to secure the cannula.Manufacturing controls include inspections during production for visual defects including cracks, tears, inclusions, discoloration and stretching or deformation.Any product that fails the visual inspection is disposed of.The subject opt980e optiflow + mask interface adapter would have met the required specifications.The user instructions which accompany the opt980e optiflow + mask interface adapter show in pictorial format the correct placement and fitting of the interface, including ensuring that the lanyard is appropriately worn, and warns: - "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 ; 9494534002
• MDR Report Key: 13310192
• MDR Text Key: 286361675
• Report Number: 9611451-2022-00079
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012436948
• UDI-Public: (01)09420012436948(10)2101647655(11)210531
• 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,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/23/2021

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: Health Professional
• Device Model Number: OPT980E
• Device Catalogue Number: OPT980
• Device Lot Number: 2101647655
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 12/23/2021
• Initial Date FDA Received: 01/20/2022
• Supplement Dates Manufacturer Received: 04/21/2022
• Supplement Dates FDA Received: 04/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2021
• 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 PT101 AIRVO 2 HUMIDIFIER; F&P PT101 AIRVO 2 HUMIDIFIER