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

Model Number	OPT980
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).We are currently in the process of finalising our investigations.We will provide a follow up report upon completion of investigations.
Event or Problem Description
A distributor reported on behalf of a healthcare facility in (b)(6) that the tubing of an opt980 mask interface adapter was broken prior to patient use.There was no patient involvement.
Additional Manufacturer Narrative
(b)(4).The opt980 optiflow + mask interface adapter is an interface used to deliver humidified oxygen 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 support the weight of the circuit and prevent the cannula being dislodged.Method: the complaint opt980 optiflow + mask interface adapter was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is based on the information and photograph provided by the customer and our knowledge of the product.Results: visual inspection of the provided photograph revealed that the tubing was pulled apart next to the mask connector.Conclusion: without the complaint device, we are unable to determine the cause of the reported event.However, the reported event is likely due to pulling at the tube.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 rejected.The subject opt980 optiflow + mask interface adapter would have met the required specifications at the time of production.The user instructions which accompany the opt980 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, to prevent loss of therapy." - "failure to use the set-up described above can compromise performance and affect patient safety.".
Event or Problem Description
A distributor reported on behalf of a healthcare facility in china that the tubing of an opt980 optiflow + mask interface adapter was broken prior to patient use.There was no patient involvement.

• Brand Name: OPTIFLOW + MASK INTERFACE ADAPTER
• Common Device Name: BTT
• MDR Report Key: 12419216
• Report Number: 9611451-2021-01029
• Device Sequence Number: 1207431
• Product Code: BTT
• UDI-Device Identifier: 09420012436931
• UDI-Public: (01)09420012436931(10)2101527611(11)210226
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: distributor,foreign,health pr
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2021

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: 2101527611
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/06/2021
• Supplement Date Received by Manufacturer: 09/06/2021
• Initial Report FDA Received Date: 09/03/2021
• Supplement Report FDA Received Date: 10/05/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: F&P 900PT561 HEATED BREATHING TUBE AND CHAMBER KIT.; F&P PT101 AIRVO 2 HUMIDIFIER.