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

Model Number OPT1044

Device Problems Device Slipped (1584); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint opt1044 optiflow adult nasal cannula is currently en route to fisher & paykel healthcare (f&p) for evaluation.We will provide a follow up report upon completion of investigation.

Event Description

A healthcare facility in (b)(6) reported via a fisher and paykel healthcare (f&p) field representative reported that the tubing of an opt1044 optiflow adult nasal cannula slipped away from the nasal prongs.There were no patient consequences.

Manufacturer Narrative

(b)(4).The opt1044 optiflow 3s adult nasal cannula interface is used to deliver nasal high flow (nhf) therapy to spontaneously breathing adult 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 buckle 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 opt1044 optiflow + adult nasal cannula was received at fisher & paykel healthcare (f&p) in new zealand for investigation, where it was visually inspected.Results: visual inspection revealed no fault found with the opt1044 optiflow + adult nasal cannula.Conclusion: we are unable to determine what may have caused the reported event as no fault was found with the device.However, the reported event was most likely as a result of the cannula tube clip not being connected to the cannula all optiflow interfaces are inspected during production for visual defects including cracks, tears, inclusions, discolouration and stretching or deformation.Any product that fails the visual inspection is disposed of.The setup instructions in the user instructions which accompany the opt1044 optiflow 3s adult nasal cannula include the following steps: - use headgear buckle to apply and remove the cannula from the patient.- the headgear straps can be separated for extra stability.- ensure tubing connection is properly inserted.- reconnect cannula tube clip to cannula side before use.- attach tubing clip to breathing circuit.The user instructions also contain the following warnings/cautions: - do not crush or stretch tube, to prevent loss of therapy.- failure to follow the fitting instructions can compromise performance and affect patient safety.

Event Description

A healthcare facility in new jersey reported via a fisher and paykel healthcare (f&p) field representative reported that the tubing of an opt1044 optiflow adult nasal cannula slipped away from the nasal prongs.There were no patient consequences.

• Brand Name: OPTIFLOW + ADULT NASAL CANNULA
• Type of Device: BTT
• 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: faranak gomarooni ; 17400 laguna canyon road; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 14247479
• MDR Text Key: 294658938
• Report Number: 9611451-2022-00415
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012435378
• UDI-Public: (01)09420012435378(10)2101603942(11)210419
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191818
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 04/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OPT1044
• Device Catalogue Number: OPT1044
• Device Lot Number: 2101603942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 07/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2021
• 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