MAUDE Adverse Event Report: ADULT MASK INTERFACE ADAPTER; BZA

Model Number	OPT980
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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 or Problem 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.
Additional 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.".

• Brand Name: ADULT MASK INTERFACE ADAPTER
• Common Device Name: BZA
• MDR Report Key: 11676207
• Report Number: 9611451-2021-00403
• Device Sequence Number: 4175639
• Product Code: BZA
• UDI-Device Identifier: 09420012436948
• UDI-Public: (01)09420012436948(10)210131020011200930
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2021

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
• Operator of Device: Health Professional
• Device Model Number: OPT980
• Device Catalogue Number: OPT980
• Device Lot Number: 2101310200
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/18/2021
• Supplement Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 04/15/2021
• Supplement Report FDA Received Date: 06/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1