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

Model Number OPT980E

Device Problem 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 opt980e optiflow + mask interface adapters were detaching from the connectors after a couple of weeks of use.There were no reported patient consequences.

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 opt980e optiflow + mask interface adapters were detaching from the connectors after a couple of weeks of use.There were no reported patient consequences.

Manufacturer Narrative

(b)(4).The opt980e optiflow + mask interface adapter is used to deliver humidified respiratory gases 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 to remove the load of the breathing circuit from the patient's interface.Method: f&p healthcare contacted the customer multiple times in order to obtain additional information and the complaint opt980e optiflow + mask interface adapters.However, no further information was provided.Our investigation is based on the information and photograph provided by the customer, and our knowledge of the product.Results: visual inspection of the provided photograph revealed that the tubing of one of the complaint opt980e optiflow + mask interface adapters was detached from the 3-way connector.Furthermore, it was noted that the tubing was stretched and torn at the connector end and the lanyard was removed from the opt980e device.Conclusion: without the return of the opt980e optiflow + mask interface adapters or further information, we are unable to determine the cause of the reported damages.However, based on our knowledge of the product and the photograph showing parts of the tubing of one of the complaint opt980e optiflow + mask interface adapters being stretched, the reported event was likely caused by the cannula being subjected to excessive force.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 disposed of.The subject opt980e optiflow + mask interface adapters 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 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.".

Event Description

A distributor in canada reported, via a fisher & paykel healthcare (f&p) field representative, that the tubing of opt980e optiflow + mask interface adapters were detaching from the connectors after a couple of weeks of use.There were no reported patient consequences.

• 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: 13256597
• MDR Text Key: 286249638
• Report Number: 9611451-2022-00039
• 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,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/16/2021

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: OPT980E
• Device Catalogue Number: OPT980
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2021
• Initial Date FDA Received: 01/13/2022
• Supplement Dates Manufacturer Received: 03/20/2022
• Supplement Dates FDA Received: 04/09/2022
• 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