MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD OPTIFLOW ADULT NASAL CANNULA; CAT

Model Number	OPT844
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	05/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product background: the opt844 optiflow adult nasal cannula is a nasal cannula patient interface for delivery of humidified respiratory gases, including those who are receiving nasal high flow therapy (nhf).Optiflow + interfaces are designed for use with the airvo 2 series of humidification devices.Nhf therapy and the airvo 2 device are intended for use with spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases.The airvo 2 device should not be used for life support purposes, and appropriate patient monitoring must be used at all times.The opt844 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 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 nares.Method: the complaint opt844 nasal cannula was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is thus based on the information and photograph provided by the customer and our knowledge of the product.Result: visual inspection of the provided photograph revealed that the tubing of an opt844 nasal cannula was detached from the manifold.The healthcare facility reported that the patient was restless during the use of the device.Conclusion: without the return of the subject device, we are unable to determine the cause of the reported event.However, based on our product knowledge and the healthcare facility's report that the patient was restless, the reported event was likely caused by the cannula being subjected to excessive force during use.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 cannula would have met the specification at the time of production.The setup instructions in the user instructions which accompany the opt844 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: - "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 or Problem Description
A healthcare facility in china reported that the tubing of an opt844 optiflow adult nasal cannula was found detached from the manifold during use.There were no patient consequences.

• Brand Name: OPTIFLOW ADULT NASAL CANNULA
• Common Device Name: CAT
• 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 ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494534002
• MDR Report Key: 14725595
• Report Number: 9611451-2022-00562
• Device Sequence Number: 2227115
• Product Code: CAT
• UDI-Device Identifier: 09420012432124
• UDI-Public: (01)09420012432124(10)2100937434(11)191113
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/18/2022

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: OPT844
• Device Catalogue Number: OPT844
• Device Lot Number: 2100937434
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2022
• Initial Report FDA Received Date: 06/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2019
• 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 900PT501 TUBE AND CHAMBER KIT; F&P PT101 AIRVO 2 HUMIDIFIER
• Patient Sex: Unknown