• 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; BTT

  • 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; BTT Back to Search Results
Model Number OPT944
Device Problem Break (1069)
Patient Problem Low Oxygen Saturation (2477)
Event Date 06/05/2022
Event Type  malfunction  
Event Description
A healthcare facility in china reported that an opt944 optiflow + adult nasal cannula was found broken after two days of use.It was reported that the patient desaturated to 90% spo2.Sputum aspiration was performed and the patient's spo2 dropped to 89%.The subject cannula was then replaced, the patient recovered to 96% spo2.There were no further patient consequences.The patient was discharged from the hospital.
 
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 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 opt944 optiflow + adult nasal cannula was requested by fisher & paykel healthcare (f&p) for evaluation, however the complaint opt944 optiflow + nasal cannula was not returned.Results: the customer has stated the opt944 optiflow + adult nasal cannula was in use for two days when, the nurse found the patient desaturated to 90% spo2.Sputum aspiration was performed, and the subject cannula was then replaced, the patient recovered to 96% spo2.The set up was inspected and opt944 optiflow + adult nasal cannula was found broken near the 3-way connector and manifold.The patient has since been discharged with no further consequences.Conclusion: without the return of the complaint opt944 optiflow + adult nasal cannula, we are unable to determine the cause of the reported event.However, based on our knowledge of the product, and that the cannula was in use for two days without incident the reported damage is likely to have been caused by the tubing 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 opt944 optiflow + adult nasal cannula would therefore 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 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.".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
9494534000
MDR Report Key15020291
MDR Text Key297068632
Report Number9611451-2022-00612
Device Sequence Number1
Product Code BTT
UDI-Device Identifier09420012429117
UDI-Public(01)09420012429117(10)2101888437(11)211110
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 Other,Foreign,User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 06/17/2022
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 NumberOPT944
Device Catalogue NumberOPT944
Device Lot Number2101888437
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/17/2022
Initial Date FDA Received07/14/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/10/2021
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
FISHER AND PAYKEL 900PT561 AIRVO HEATED BREATHING; FISHER AND PAYKEL PT101 AIRVO 2 HUMIDIFIER
-
-