Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD OPTIFLOW + ADULT NASAL CANNULA
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

FISHER & PAYKEL HEALTHCARE LTD OPTIFLOW + ADULT NASAL CANNULA Back to Search Results
Model Number OPT944
Device Problems Stretched (1601); Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/01/2023
Event Type  malfunction  
Event Description
A healthcare facility in united kingdom reported via a fisher and paykel healthcare (f&p) field representative that the tubing of an opt944 + adult nasal cannula was found damaged during patient use.There was no patient consequence.
 
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).Optiflow + interfaces are designed for use with the airvo 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.
 
Manufacturer Narrative
(b)(4), corrected data: d2,d3,d8,g1,g3,h2,h3,h6.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 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 healthcare facility returned four complaint opt944 optiflow + adult nasal cannulas to f&p new zealand for investigation, for five logged complaints.These are submitted under the following mfr numbers 9611451-2023-00594, 9611451-2023-00595, 9611451-2023-00596, 9611451-2023-00597, 9611451-2023-00598.The complaint (b)(4) optiflow + adult nasal cannulas were not labelled and therefore we are unable to determine which complaint device is associated with each incident.The four complaint opt944 optiflow + adult nasal cannulas were investigated.One of the complaint opt944 optiflow + adult nasal cannula was not returned to f&p for evaluation.Our investigation is based on our evaluation of the four returned subject devices, information and photographs provided by the healthcare facility, previous investigations of similar complaints, and our knowledge of the product.Results: the healthcare facility reported that all five opt944 cannula were broken and there were no patient consequences.Investigations of the four received subject devices are as below: device one: visual inspection of the opt944 optiflow + adult nasal cannula revealed that the tubing was torn near the three-way connector and one side of the nasal prongs was pulled off the manifold which indicates the damage was consistent with an external force being applied to the tubing.Device two and three: visual inspection of the opt944 optiflow + adult nasal cannulas revealed that the tubing was torn near the three-way connector and parts of the tubing was found stretched which indicates the damage was consistent with an external force being applied to the tubing.Device four: visual inspection of the opt944 optiflow + adult nasal cannula revealed that parts of the tubing was found stretched which indicates an external force being applied to the tubing.However, the tubing was not torn.Device five was not returned and we are unable to match the photographs and information received from the healthcare facility to this exact reported fault.There were no reported patient consequences.Conclusion: our investigation was unable to determine the exact cause of the damage to the opt944 optiflow + adult nasal cannulas.Based on our knowledge of the product and the type of damage observed, all four subject devices received were found stretched which indicates that the tubing was likely subjected to excessive force during patient use.Without the return of one of the subject devices, we are unable to determine the exact cause of the damage to the opt944 optiflow + adult nasal cannula.Based on our knowledge of the product, the tubing may have been subjected to excessive force during patient 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: "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 healthcare facility in united kingdom reported via a fisher and paykel healthcare (f&p) field representative that the tubing of an opt944 + adult nasal cannula was found damaged during patient use.There was no patient consequence.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key17234832
MDR Text Key318294881
Report Number9611451-2023-00596
Device Sequence Number1
Product Code BTT
UDI-Device Identifier09420012429117
UDI-Public(01)09420012429117(10)2100979633(11)200113
Combination Product (y/n)N
Reporter Country CodeUK
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
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/01/2023
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 NumberOPT944
Device Catalogue NumberOPT944
Device Lot Number2100979633
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/27/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/01/2023
Initial Date FDA Received06/29/2023
Supplement Dates Manufacturer Received08/14/2023
Supplement Dates FDA Received09/13/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/13/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-