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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD OPTIFLOW + ASYMMETRICAL NASAL CANNULA
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FISHER & PAYKEL HEALTHCARE LTD OPTIFLOW + ASYMMETRICAL NASAL CANNULA Back to Search Results
Model Number OPT962
Device Problems Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
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 opt962 optiflow + asymmetrical 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 airvo series humidifiers and are also compatible with the fisher & paykel healthcare (f&p) mr850 and 950 humidification system devices.Optiflow + interfaces are intended for use with spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases.Optiflow + interfaces are not intended for life support and appropriate patient monitoring must be used at all times.
 
Event Description
A healthcare facility in brazil reported via a fisher & paykel healthcare (f&p) field representative that the tubing of an opt962 optiflow + asymmetrical nasal cannula was found damaged during use.There was no patient consequence.
 
Event Description
A healthcare facility in brazil reported via a fisher & paykel healthcare (f&p) field representative that the tubing of an opt962 optiflow + asymmetrical nasal cannula was found damaged during use.There was no patient consequence.
 
Manufacturer Narrative
(b)(4).Product background: the opt962 optiflow + asymmetrical 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 airvo series humidifiers and are also compatible with the fisher & paykel healthcare (f&p) mr850 and 950 humidification system devices.Optiflow + interfaces are intended for use with spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases.Optiflow + interfaces are not intended for life support and appropriate patient monitoring must be used at all times.Method: the complaint opt962 optiflow + asymmetrical nasal cannula was not returned to f&p for evaluation.Our investigation is based on the information and photograph provided by the healthcare facility, previous investigations of similar complaints, and our knowledge of the product.Results: visual inspection of the provided photograph revealed that the tubing of the opt962 optiflow + asymmetrical nasal cannula was detached from the 3-way connector.Based on the photograph provided, there is no indication that the tube was stretched.Conclusion: our investigation was unable to determine the cause of the observed damage to the opt962 optiflow + asymmetrical nasal cannula.Manufacturing controls include inspections during production for visual defects to the optiflow + tubing and the swivel, including cracks, tears, moulding defects, contamination, inclusions, discoloration and stretching or deformation.The optiflow + tubing is also inspected for any assembly defects, including confirmation the swivel and 3-way connector are connected with the correct engagement.The subject opt962 optiflow + asymmetrical nasal cannula would have met the required specifications.The user instructions which accompany the opt962 optiflow + asymmetrical 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: - "do not crush or stretch tube, to prevent loss of therapy." - "ensure that patients in an awake prone position (i.E.On their stomach) are not lying on the interface tubing or heated breathing tube.Reposition the breathing tube clip if required.Failure to comply may result in damage to the device, causing loss of therapy." - "ensure head strap clip is attached, to prevent cannula from being pulled out of the nares." - "appropriate patient monitoring (e.G.Oxygen saturation) must be used at all times.Failure to monitor the patient (e.G.In an event of an interruption to gas flow) may result in loss of therapy, serious injury or death." - "failure to use the setup described above can compromise performance and affect patient safety.".
 
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Brand Name
OPTIFLOW + ASYMMETRICAL NASAL CANNULA
Type of Device
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 Key18243544
MDR Text Key329469681
Report Number9611451-2023-01113
Device Sequence Number1
Product Code BTT
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K231956
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/01/2023
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
Device Operator Health Professional
Device Model NumberOPT962
Device Catalogue NumberOPT962
Device Lot Number2102326022
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/01/2023
Initial Date FDA Received11/30/2023
Supplement Dates Manufacturer Received11/01/2023
Supplement Dates FDA Received02/28/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/31/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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