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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ADULT MASK INTERFACE ADAPTER; BZA
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ADULT MASK INTERFACE ADAPTER; BZA Back to Search Results
Model Number OPT980
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The complaint (b)(4) mask interface adapter is currently en route to fisher & paykel healthcare (f&p) new zealand for evaluation.We will provide a follow up report upon completion of investigation.
 
Event Description
A distributor in canada reported via a fisher & paykel healthcare (f&p) representative that an opt980 mask interface adapter broke between the tubing and connector.There was no reported patient consequence.
 
Event Description
A distributor in canada reported via a fisher & paykel healthcare (f&p) representative that an opt980 mask interface adapter broke between the tubing and connector.There was no reported patient consequence.
 
Manufacturer Narrative
(b)(4).The opt980 interface is used to deliver humidified oxygen to patients.The opt980 consists of a lightweight delivery tube which is connected to a rigid plastic base and soft nasal prongs (nasal interface).The interface is held in place by a head strap and also includes a lanyard that is placed around the patient's neck or attached to the patient's clothing or bedding to remove the load of the breathing circuit from the patient's nares.Method: the complaint opt980 optiflow + nasal cannula was not returned to fisher & paykel healthcare (f&p) for investigation.Therefore, our investigation is based off the information and photograph provided by the customer and our knowledge of the product.Results: visual inspection of photograph provided by the customer revealed that the opt944 optiflow + nasal cannula was found detached from the swivel connector.Conclusion: without the complaint device, we are unable to determine the cause of the reported event.All optiflow interfaces are inspected during production for visual defects including cracks, tears, inclusions, discoloration and stretching or deformation.Any product that fails the visual inspection is disposed of or reprocessed.The subject opt980 optiflow adult nasal cannula would have met the required specification at the time of production.The setup instructions in the user instructions which accompany the opt980 optiflow + adult nasal cannula include the following steps: "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." the user instructions also contain the following warnings/cautions: "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
ADULT MASK INTERFACE ADAPTER
Type of Device
BZA
MDR Report Key11676207
MDR Text Key247927503
Report Number9611451-2021-00403
Device Sequence Number1
Product Code BZA
UDI-Device Identifier09420012436948
UDI-Public(01)09420012436948(10)210131020011200930
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 03/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberOPT980
Device Catalogue NumberOPT980
Device Lot Number2101310200
Was Device Available for Evaluation? No
Date Manufacturer Received05/19/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/30/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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