MAUDE Adverse Event Report: ADULT NASAL INTERFACE; BTT

Model Number OPT944

Device Problems Disconnection (1171); Connection Problem (2900)

Patient Problem Low Oxygen Saturation (2477)

Event Date 02/03/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are currently in the process of obtaining additional information from the customer for evaluation.We will provide a follow-up report upon completion of our investigation.

Event Description

A distributor in (b)(6) reported on behalf of a healthcare facility, via a fisher & paykel healthcare (f&p) field representative, that the tubing of an opt944 optiflow + adult nasal cannula disconnected from the breathing circuit during use.It was also reported that the patient spo2 levels decreased.No further patient consequences were reported.

Event Description

A distributor in brazil reported on behalf of a healthcare facility, via a fisher & paykel healthcare (f&p) field representative, that the tubing of an opt944 optiflow + adult nasal cannula disconnected from the breathing circuit during use.It was also reported that the patient spo2 levels decreased.No further patient consequences were reported.

Manufacturer Narrative

(b)(4).We followed up with the customer in order to obtain additional information regarding the incident however no further information was received.The opt944 optiflow + adult nasal cannula is an interface used to deliver humidified oxygen to patients and consists of a lightweight delivery tube connected to a rigid plastic base and soft nasal prongs (nasal interface).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 not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is, thus, based on the information provided by the customer, and our knowledge of our product.Results: the customer reported that the tubing of an opt944 optiflow + adult nasal cannula disconnected from the breathing circuit during use.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.The subject cannula would have met the specification at the time of production.The setup instructions in the user instructions which accompany the opt944 optiflow + adult nasal cannula include the following steps: "ensure headstrap 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: "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 NASAL INTERFACE
• Type of Device: BTT
• MDR Report Key: 11467893
• MDR Text Key: 249057746
• Report Number: 9611451-2021-00280
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• PMA/PMN Number: K162553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 02/12/2021

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
• Device Operator: Health Professional
• Device Model Number: OPT944
• Device Catalogue Number: OPT944
• Device Lot Number: 2101124443
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/12/2021
• Initial Date FDA Received: 03/11/2021
• Supplement Dates Manufacturer Received: 03/15/2021
• Supplement Dates FDA Received: 04/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: F&P RT 202 ADULT BREATHING CIRCUIT.; F&P RT 202 ADULT BREATHING CIRCUIT.