MAUDE Adverse Event Report: OPTIFLOW + ADULT NASAL INTERFACE; BTT

Model Number OPT944

Device Problems Loose or Intermittent Connection (1371); Mechanical Problem (1384)

Patient Problem Low Oxygen Saturation (2477)

Event Date 12/22/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are currently in the process of obtaining further information.We will provide a follow up report upon completion of investigation.

Event Description

A healthcare facility in (b)(6) reported via a fisher & paykel field representative that one of the prongs of the opt944 optiflow + adult nasal cannula became loose during use.The patient experienced oxygen desaturation, however recovered once the cannula was replaced.There was no further patient consequences.

Event Description

A healthcare facility in sweden reported via a fisher & paykel field representative that one of the prongs of the opt944 optiflow + adult nasal cannula became loose during use.The patient experienced oxygen desaturation, however recovered once the cannula was replaced.There was no further patient consequences.

Manufacturer Narrative

(b)(4).The opt944 optiflow + nasal interface is 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 opt944 optiflow + adult nasal cannula was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is based on the information provided by the customer and our knowledge of the product.Results: the customer reported that one of the prongs of the opt944 optiflow + adult nasal cannula became loose 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 setup instructions in the user instructions which accompany the opt944 optiflow + 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: - 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: OPTIFLOW + ADULT NASAL INTERFACE
• Type of Device: BTT
• MDR Report Key: 11468030
• MDR Text Key: 243343197
• Report Number: 9611451-2021-00275
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2021
• 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: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/31/2021
• 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 AIRVO 2 HUMIDIFIER; F&P AIRVO 2 HUMIDIFIER