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

Model Number	OPT980
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).We are currently in the process of completing our investigation.We will provide a follow up report upon completion of investigation.
Event or Problem Description
A distributor in (b)(6) reported via fisher paykel healthcare (f&p) field presentative that the tubing of an opt980 optiflow + mask interface adaptor was found damaged.There was no patient involvement.
Additional Manufacturer Narrative
(b)(4).The opt980e optiflow + mask interface adaptor 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 or attached to the patient's clothing or bedding to remove the load of the breathing circuit from the patient's interface.Method: the complaint opt980e optiflow + mask interface adaptor was returned to fisher & paykel healthcare (f&p) in new zealand where it was visually inspected.Result: visual inspection of the returned opt980e optiflow + mask interface adapter revealed that the tubing was stretched and detached at the 3-way connector end.The tubing was also stretched at the mask adaptor end.Conclusion: we are unable to determine the cause of the reported event.However, it is likely due to pulling at the tube.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 interface 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."; "failure to use the set-up described above can compromise performance and affect patient safety.".
Event or Problem Description
A distributor in canada reported via a fisher and paykel healthcare (f&p) field representative that the tubing of an opt980e optiflow + mask interface adaptor was found damaged.There was no patient involvement.

• Brand Name: OPTIFLOW + MASK INTERFACE ADAPTOR
• Common Device Name: 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: 12458024
• Report Number: 9611451-2021-01060
• Device Sequence Number: 14519191
• Product Code: BTT
• UDI-Device Identifier: 09420012436948
• UDI-Public: (01)09420012436948(10)2101647655(11)210531
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K162553
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2021

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
• Operator of Device: Lay User/Patient
• Device Model Number: OPT980
• Device Catalogue Number: OPT980
• Device Lot Number: 2101647655
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2021
• Supplement Date Received by Manufacturer: 10/13/2021
• Initial Report FDA Received Date: 09/12/2021
• Supplement Report FDA Received Date: 11/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown