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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD OPTIFLOW + ADULT NASAL CANNULA
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FISHER & PAYKEL HEALTHCARE LTD OPTIFLOW + ADULT NASAL CANNULA Back to Search Results
Model Number OPT944
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/29/2023
Event Type  malfunction  
Event Description
A distributor reported on behalf of a healthcare facility in china via a fisher & paykel healthcare (f&p) field representative that the tubing of an opt944 optiflow + adult nasal cannula was found damaged near the manifold during device set up.There was no patient involvement as the issue was found whilst the device was not in use on a patient.
 
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 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).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 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.
 
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).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 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 opt944 optiflow + adult nasal cannula was not returned to f&p for evaluation as it was discarded.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 opt944 optiflow + adult nasal cannula was damaged near the manifold.Conclusion: our investigation was unable to determine the cause of the reported damage.Based on our knowledge of the product, the reported damage is likely to have been caused by the tubing being subjected to excessive force.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: - "do not crush or stretch tube, to prevent loss of therapy." - "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." - "failure to use the set-up described above can compromise performance and affect patient safety.".
 
Event Description
A distributor reported on behalf of a healthcare facility in china via a fisher & paykel healthcare (f&p) field representative that the tubing of an opt944 optiflow + adult nasal cannula was found damaged near the manifold during device set up.There was no patient involvement as the issue was found whilst the device was not in use on a patient.
 
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Brand Name
OPTIFLOW + ADULT 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 Key18352691
MDR Text Key331074666
Report Number9611451-2023-01172
Device Sequence Number1
Product Code BTT
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K162553
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative,Distributor
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 11/30/2023
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 NumberOPT944
Device Catalogue NumberOPT944
Device Lot Number2102092770
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/30/2023
Initial Date FDA Received12/18/2023
Supplement Dates Manufacturer Received01/30/2024
Supplement Dates FDA Received02/14/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/23/2022
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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