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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 OPT942
Device Problems Break (1069); Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/25/2022
Event Type  malfunction  
Manufacturer Narrative
(b)(4).We are currently in the process of completing our investigation.We will provide a follow up report upon completion of investigation.Product background: the opt942 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 and the airvo 2 device are intended for use with spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases.The airvo 2 device 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.
 
Event Description
A distributor reported on behalf of a healthcare facility in china that the interface of an opt942 optiflow + adult nasal cannula was found damaged during patient use.There were no patient consequences.
 
Event Description
A distributor reported on behalf of a healthcare facility in china that the interface of an opt942 optiflow + adult nasal cannula was found damaged during patient use.There were no patient consequences.
 
Manufacturer Narrative
(b)(4).Product background: the opt942 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 and the airvo 2 device are intended for use with spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases.The airvo 2 device 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: the complaint opt942 optiflow + adult nasal cannula was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is thus based on the information and photograph provided by the customer, and our knowledge of the product.Result: the healthcare facility reported that the interface of the complaint opt942 was found damaged.The healthcare facility further reported that the patient had tried removing the cannula.Visual inspection of the provided photograph confirmed that the interface was broken at the right side.Conclusion: without the return of the complaint device, we are unable to determine the cause of the reported event.However, based on our knowledge of the product and the healthcare facility's report that the patient tried to remove the cannula, the reported event was likely caused by the cannula being subjected to excessive force during use.Manufacturing controls include inspections during production for visual defects including cracks, tears, inclusions, discoloration and stretching or deformation.Any product that fails the visual inspection is disposed of.The subject opt942 optiflow + adult nasal cannula would have met the required specifications.The user instructions which accompany the opt942 optiflow + adult nasal cannula show in pictorial format the correct placement and fitting of the cannula, including ensuring the headstrap clip and the tubing clip are appropriately attached.The user instructions also warn: - "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.
 
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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
irvine, CA 92618
9494534002
MDR Report Key14783974
MDR Text Key295975867
Report Number9611451-2022-00575
Device Sequence Number1
Product Code BTT
UDI-Device Identifier09420012428493
UDI-Public(01)09420012428493(10)2101712820(11)210709
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,Distributor
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 05/27/2022
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 NumberOPT942
Device Catalogue NumberOPT942
Device Lot Number2101712820
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/27/2022
Initial Date FDA Received06/22/2022
Supplement Dates Manufacturer Received06/28/2022
Supplement Dates FDA Received07/13/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/09/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
F&P 900PT561 HEATED BREATHING TUBE AND CHAMBER KIT.; F&P 900PT561 HEATED BREATHING TUBE AND CHAMBER KIT.
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