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

Model Number	OPT942E
Medical Device Problem Code	Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A patient in (b)(6) reported that the manifold of an opt942e optiflow + adult nasal cannula had a loose connection with the interface.The patient reported that they had been using the subject cannula twice a day for several months without the head strap clip.There was no patient consequence.
Additional Manufacturer Narrative
(b)(4).Fisher & paykel healthcare (f&p) is currently in the process of completing our investigation.We will provide a follow up report upon completion of our investigation.Product background: the opt942e 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 myairvo 2 series of humidification devices and is also compatible with the f&p mr850 and 950 humidification system devices.Nhf therapy is intended for use with spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases nhf therapy should not be used for life support purposes, and appropriate patient monitoring must be used at all times.The cannula consists of a lightweight delivery tube connected to a rigid plastic base and soft nasal prongs (nasal interface).This allows the device to be light weight and durable.The interface is held in place by a head strap and features a head strap clip which works in tandem with the tubing clip (attaches to the patient's clothing/bedding) to support the weight of the circuit and prevent the cannula being dislodged.The user instructions which accompany the opt942e optiflow + adult nasal cannula show in pictorial format the correct placement and fitting of the cannula, including ensuring the head strap clip and the tubing clip are appropriately attached.The user instructions also state: "this product is intended to be used for a maximum of 30 days." "ensure headstrap clip is attached to the headstrap, to prevent cannula from being pulled out of the nares." "the cannula can become unattached if not used with the headstrap clip." "adjust headstrap to fit.Do not over-tighten." "select appropriate size.Prongs must not create a seal in the nares.A clear gap must be visible around each prong.".
Event or Problem Description
A patient in north carolina reported that the manifold of an opt942e optiflow + adult nasal cannula had a loose connection with the interface.The patient reported that they had been using the subject cannula twice a day for several months without the head strap clip.There were no reported patient consequences.
Additional Manufacturer Narrative
Product background: the opt942e 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).The cannula consists of a lightweight delivery tube connected to a rigid plastic base and soft nasal prongs (nasal interface).This allows the device to be light weight and durable.The interface is held in place by a head strap and features a head strap clip which works in tandem with the tubing clip (attaches to the patient's clothing/bedding) to support the weight of the circuit and prevent the cannula being dislodged.Optiflow + interfaces are designed for use with the myairvo 2 series of humidification devices and is also compatible with the fisher & paykel healthcare (f&p) mr850 and 950 humidification system devices.Nhf therapy is intended for use with spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases nhf therapy should not be used for life support purposes, and appropriate patient monitoring must be used at all times.Method: the complaint opt942e optiflow + adult nasal cannula was not returned to f&p for evaluation.F&p made multiple requests for the return of the device and photographs of the reported damage.However, the device was not returned, and no photos were provided.Therefore, our investigation is based on the information provided by the patient, and our knowledge of the product.Results: the patient has stated that the manifold opt942e optiflow + adult nasal cannula had a loose connection with the interface.The patient also stated that they had been using the same subject cannula for several months without the white head strap clip.There were no patient consequences reported.Conclusion: without any photos provided by the patient or the return of the subject device, f&p is unable to confirm the reported damage.F&p's manufacturing controls for the optiflow + tubing include inspections during production for visual defects including cracks, tears, moulding defects, contamination, inclusions, discoloration and stretching or deformation.The subject opt942e optiflow + adult nasal cannula would have met the required specifications.The user instructions which accompany the opt942e optiflow + adult nasal cannula show in pictorial format the correct placement and fitting of the cannula, including ensuring the head strap clip and the tubing clip are appropriately attached.The user instructions also state: "this product is intended to be used for a maximum of 30 days." "ensure headstrap clip is attached to the headstrap, to prevent cannula from being pulled out of the nares." "the cannula can become unattached if not used with the headstrap clip." "adjust headstrap to fit.Do not over-tighten." "select appropriate size.Prongs must not create a seal in the nares.A clear gap must be visible around each prong.".

• Brand Name: OPTIFLOW + ADULT NASAL CANNULA
• Common Device Name: NASAL CANNULA
• 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: omid taheri ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 8007923912
• MDR Report Key: 17313654
• Report Number: 9611451-2023-00644
• Device Sequence Number: 15009182
• Product Code: BTT
• UDI-Device Identifier: 09420012429711
• UDI-Public: (01)09420012429711(10)2101889959(11)211118
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K162553
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2023

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: OPT942E
• Device Catalogue Number: OPT942E
• Device Lot Number: 2101889959
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2023
• Supplement Date Received by Manufacturer: 08/07/2023
• Initial Report FDA Received Date: 07/12/2023
• Supplement Report FDA Received Date: 09/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2021
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: F&P PT100 MYAIRVO 2 HUMIDIFIER.; F&P PT100 MYAIRVO 2 HUMIDIFIER.
• Patient Sex: Unknown