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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD OPTIFLOW + ADULT NASAL CANNULA; BTT
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FISHER & PAYKEL HEALTHCARE LTD OPTIFLOW + ADULT NASAL CANNULA; BTT Back to Search Results
Model Number OPT944
Device Problems Detachment of Device or Device Component (2907); Insufficient Information (3190); Material Split, Cut or Torn (4008)
Patient Problem Low Oxygen Saturation (2477)
Event Type  malfunction  
Event Description
A healthcare facility in the netherlands reported via a fisher & paykel healthcare (f&p) field representative that an opt944 optiflow + adult nasal cannula was found damaged.The healthcare facility reported the following sequence of events: a patient desaturated to 88% spo2, the tubing of an opt944 optiflow + adult nasal cannula was found damaged.It was reported that during replacement with another opt944 optiflow + adult nasal cannula, this cannula broke.This cannula was also subsequently replaced, and no further patient consequences were reported.
 
Manufacturer Narrative
(b)(4).Product background: the opt944 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 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.We are currently in the process of retrieving the subject opt944 optiflow + adult nasal cannula for evaluation.We will provide a follow up report upon completion of our investigation.
 
Manufacturer Narrative
(b)(4).Product background: the opt944 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 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.Method: one of the complaint opt944 optiflow + adult nasal cannulas was received at fisher & paykel healthcare (f&p) in new zealand for investigation, where it was visually inspected.Our investigation is based on our evaluation of the subject device, information provided by the customer, previous investigations of similar complaints, and our knowledge of the product.Results: the complaint opt944 was returned without the 3-way connector.Visual inspection of the opt944 optiflow + adult nasal cannula revealed that the tubing was found torn and stretched.Conclusion: our investigation was unable to determine the exact cause of the observed damage to the opt944 optiflow +adult nasal cannula.However, based on our knowledge of the product, the type of damage observed, and our observation that the tubing was stretched, the reported damage is likely to have been caused by the tubing being subjected to excessive force during use.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 opt944 optiflow + adult nasal cannula would have met the required specifications.The user instructions which accompany the opt944 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: "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." "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.".
 
Event Description
A healthcare facility in the netherlands reported via a fisher & paykel healthcare (f&p) field representative that an opt944 optiflow + adult nasal cannula was found damaged.The healthcare facility reported the following sequence of events: a patient desaturated to 88% spo2, the tubing of an opt944 optiflow + adult nasal cannula was found damaged.It was reported that during replacement with another opt944 optiflow + adult nasal cannula, this cannula broke.This cannula was also subsequently replaced, and no further patient consequences were reported.
 
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Brand Name
OPTIFLOW + ADULT NASAL CANNULA
Type of Device
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
17400 laguna canyon road
suite 300
suite 300, CA 92618
9494534002
MDR Report Key15867277
MDR Text Key304341623
Report Number9611451-2022-01093
Device Sequence Number1
Product Code BTT
UDI-Device Identifier09420012429117
UDI-Public(01)09420012429117(10)2101535300(11)210303
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K162553
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 10/30/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/27/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberOPT944
Device Catalogue NumberOPT944
Device Lot Number2101535300
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received05/04/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/03/2021
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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