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

Model Number	OPT980
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2021
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 the investigation.
Event or Problem Description
A distributor reported on behalf of a healthcare facility in (b)(6) via a fisher and paykel field representative (f&p) that the tubing of an opt980 optiflow + mask interface adapter was damaged before patient use.There was no patient involvement.
Event or Problem Description
A distributor reported on behalf of a healthcare facility in china via a fisher and paykel field representative (f&p) that the tubing of an opt980 optiflow + mask interface adapter was damaged before patient use.There was no patient involvement.
Additional Manufacturer Narrative
(b)(4).Section b4: updated.The opt980 interface is used to deliver humidified oxygen to patients.The opt980 consists of a lightweight delivery tube which is connected to a rigid plastic base and soft nasal prongs (nasal interface).The interface is held in place by a head strap and also includes a lanyard that 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 nares.Method: the complaint opt980 optiflow + mask interface adapter was not returned to fisher & paykel healthcare (f&p) for investigation.Our investigation is based on the information and photographs provided by the customer and our knowledge of the product.Results: visual inspection of photographs provided revealed that the tubing opt980 optiflow + mask interface adapter was torn next to the manifold.Conclusion: without the return of the complaint device, we are unable to determine the cause of the reported event.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 opt980 optiflow + mask interface adapter would have met the required specifications.The setup instructions in the user instructions which accompany the opt980 optiflow + adult nasal cannula include the following steps: "ensure head strap clip is attached, to prevent cannula from being pulled out of the nares." "cannula can become unattached if not used with the head strap clip." "attach tubing clip to clothing/bedding to prevent cannula from pulling off face." the user instructions also contain the following warnings/cautions: -"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 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: 13337965
• Report Number: 9611451-2022-00089
• Device Sequence Number: 5475314
• Product Code: BTT
• UDI-Device Identifier: 09420012436931
• UDI-Public: (01)09420012436931(10)2101572596(11)210326
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2021

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: Health Professional
• Device Model Number: OPT980
• Device Catalogue Number: OPT980
• Device Lot Number: 2101572596
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2021
• Supplement Date Received by Manufacturer: 03/27/2022
• Initial Report FDA Received Date: 01/24/2022
• Supplement Report FDA Received Date: 04/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: F&P 900PT561 AIRVO TUBE AND CHAMBER KIT; F&P 900PT561 AIRVO TUBE AND CHAMBER KIT; F&P PT101 AIRVO 2 HUMIDIFIER; F&P PT101 AIRVO 2 HUMIDIFIER
• Patient Sex: Unknown