MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD OPTIFLOW + ADULT NASAL CANNULA

Lot Number NOT PROVIDED

Device Problem Connection Problem (2900)

Patient Problem Low Oxygen Saturation (2477)

Event Date 12/07/2023

Event Type  malfunction  

Event Description

A healthcare facility reported via a fisher & paykel healthcare (f&p) field representative that while using an f&p optiflow interface with an f&p mr850 humidifier and a nebulizer that the set up became disconnected.Information about where the disconnection occurred was not provided.It was also reported that the patient desaturated into the range of 50% spo2 at the time of the reported event.The patient was reported to have recovered from the event.F&p have requested for further details about the sequence of events including details of the device set up and where the disconnection occurred.

Manufacturer Narrative

B)(4).Fisher & paykel healthcare (f&p) is currently in the process of completing our investigation.We will provide a follow up report upon completion of our investigation.Optiflow + interfaces are designed for use with the airvo series humidifiers and are also compatible with the f&p mr850 and 950 humidification system devices.Optiflow + interfaces are intended for use with spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases.Optiflow + interfaces are not intended for life support and appropriate patient monitoring must be used at all times.

Manufacturer Narrative

(b)(4).The device details including the specific model number of the optiflow interface and circuit involved in the reported event were not provided.Optiflow + interfaces are designed for use with the airvo series humidifiers and are also compatible with the f&p mr850 and 950 humidification system devices.Optiflow + interfaces are intended for use with spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases.Optiflow + interfaces are not intended for life support and appropriate patient monitoring must be used at all times.Method: the complaint optiflow interface was not returned to f&p for evaluation.F&p requested for further details about the sequence of events including details of the device set up and where the disconnection occurred.The healthcare facility did not provide any further information despite f&p making several requests for this information.Our investigation is based on the initial information provided by the healthcare facility and our knowledge of the product.Results: the healthcare facility reported that there was a disconnection in the device setup of a nebulizer used with an optiflow interface and mr850 humidifier.Information on where the disconnection occurred was not provided.There was no reported damage.It was also reported that the patient desaturated into the range of 50% spo2 at the time of the reported event.The patient was reported to have recovered from the event.Conclusion: without further information about where the disconnection occurred, we are unable to determine the cause of the reported event.The user instructions which accompany the f&p optiflow interfaces show in pictorial format the correct placement and fitting of the device when used with an mr850 humidifier.The user instructions also state the following: "failure to use the set-up described can compromise performance and affect patient safety." "appropriate patient monitoring must be used at all times.Failure to monitor the patient may result in loss of therapy, serious injury or death.".

Event Description

A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that while using an f&p optiflow interface with an f&p mr850 humidifier and a nebulizer that the set up became disconnected.Information about where the disconnection occurred was not provided.It was also reported that the patient desaturated into the range of 50% spo2 at the time of the reported event.The patient was reported to have recovered from the event.F&p requested for further details about the sequence of events including details of the device set up and where the disconnection occurred.The healthcare facility did not provide any further information despite f&p making several requests for this information.The device details including the specific model number of the optiflow interface and circuit involved in the reported event were not provided.

• Brand Name: OPTIFLOW + ADULT NASAL CANNULA
• Type of Device: NASAL CANNULA
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: omid taheri ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 8007923912
• MDR Report Key: 18378167
• MDR Text Key: 331384216
• Report Number: 9611451-2023-01223
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/07/2023

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 Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2023
• Initial Date FDA Received: 12/21/2023
• Supplement Dates Manufacturer Received: 02/22/2024
• Supplement Dates FDA Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: No
• 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 MR850 HUMIDIFIER; F&P MR850 HUMIDIFIER