MAUDE Adverse Event Report: OPTIFLOW + MASK INTERFACE ADAPTER; BZA

Model Number	OPT980E
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).We are currently in the process of finalising our investigation.We will provide a follow up report upon completion of investigation.
Event or Problem Description
A distributor in (b)(6) reported, via a fisher & paykel healthcare (f&p) representative, that opt980 mask interface adapters were "coming apart at the base of the tubing" during use.There were no patient consequences.
Event or Problem Description
A distributor in canada reported, via a fisher & paykel healthcare (f&p) representative, that two opt980e optiflow + mask interface adapters were "coming apart at the base of the tubing" during use.There were no patient consequences.
Additional Manufacturer Narrative
(b)(4).The opt980e optiflow + mask interface adapter is used to deliver humidified respiratory gases to patients.The interface is held in place by a head strap and also includes a lanyard which 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 interface.Method: the two complaint opt980e optiflow + mask interface adapters were not returned to fisher & paykel healthcare (f&p) in new zealand.Result: the customer reported that two opt980e optiflow + mask interface adapters were "coming apart at the base of the tubing" during use.The customer later reported that the provided lanyard of the interface was not used.Conclusion: we were unable to determine the cause of the reported fault.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.The subject interfaces would have met the specification at the time of production.The user instructions which accompany the opt980e optiflow + mask interface adapter show in pictorial format the correct placement and fitting of the cannula and also warn: "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." "do not soak, wash, sterilize, or reuse this product.".

• Brand Name: OPTIFLOW + MASK INTERFACE ADAPTER
• Common Device Name: BZA
• MDR Report Key: 11241286
• Report Number: 9611451-2021-00105
• Device Sequence Number: 11694057
• Product Code: BZA
• UDI-Device Identifier: 09420012436948
• UDI-Public: (01)09420012436948(10)2101225661(11)200806
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K162553
• 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): 12/29/2020

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: OPT980E
• Device Catalogue Number: OPT980
• Device Lot Number: NP
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/29/2020
• Supplement Date Received by Manufacturer: 03/14/2021
• Initial Report FDA Received Date: 01/27/2021
• Supplement Report FDA Received Date: 04/11/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2020
• 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