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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 OPT946
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 Date 12/28/2023
Event Type  malfunction  
Manufacturer Narrative
(b)(6) fisher & paykel healthcare (f&p) has requested for the complaint device to be returned for evaluation.We will provide a follow up report upon completion of our investigation.Product background: the opt946 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 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 distributor reported on behalf of a healthcare facility in japan via a fisher and paykel healthcare (f&p) field representative that the tubing of an opt946 optiflow + adult nasal cannula was found damaged before use.There was no patient involvement as the issue was found whilst the device was not in use on a patient.
 
Manufacturer Narrative
(b)(4), product background: the opt946 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 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 opt946 optiflow + adult nasal cannula was received at 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 healthcare facility, previous investigations of similar complaints, and our knowledge of the product.Results: visual inspection of the opt946 optiflow + adult nasal cannula revealed that the tubing was the tubing of the opt946 optiflow + adult nasal cannula was detached from the manifold.The film of the tubing was wrinkled and torn which indicates the damage was consistent with an external force being applied to the tubing.Conclusion: our investigation was unable to determine the cause of the observed damage to the opt946 optiflow + adult nasal cannula.Based on the type of damage observed, and our knowledge of the product, the tubing was likely subjected to excessive force.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 opt946 optiflow + adult nasal cannula would have met the required specifications.The user instructions which accompany the opt946 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 japan via a fisher and paykel healthcare (f&p) field representative that the tubing of an opt946 optiflow + adult nasal cannula was found damaged before use.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 Key18707163
MDR Text Key335976020
Report Number9611451-2024-00111
Device Sequence Number1
Product Code BTT
UDI-Device Identifier09420012429155
UDI-Public(01)09420012429155(1002101866538(11)211028
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K162553
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative,Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 01/18/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/14/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberOPT946
Device Catalogue NumberOPT946
Device Lot Number2101866538
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received03/12/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/28/2021
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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