MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD OPTIFLOW + TRACHEOSTOMY INTERFACE; BTT

Model Number	OPT970
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A distributor reported on behalf of a healthcare facility in china that the tubing of an opt970 optiflow + tracheostomy direct connection was found damaged during use.There were no patient consequences.
Additional Manufacturer Narrative
(b)(4).We are currently in the process of completing our investigation.We will provide a follow up report upon completion of the investigation.Product background: the opt970 optiflow + tracheostomy direct connection is a patient interface used for delivery of humidified respiratory gases directly into the patient's tracheostomy.Optiflow + interfaces are designed for use with the airvo 2 series of humidification devices.The airvo 2 device is intended for use with spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases.The airvo 2 should not be used for life support purposes, and appropriate patient monitoring must be used at all times.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 remove the load of the breathing circuit from the patient's interface.
Event or Problem Description
A distributor reported on behalf of a healthcare facility in china that the tubing of an opt970 optiflow + tracheostomy direct connection was found damaged during use.There were no patient consequences.
Additional Manufacturer Narrative
(b)(4).Product background: the opt970 optiflow + tracheostomy direct connection is a patient interface used for delivery of humidified respiratory gases directly into the patient's tracheostomy.Optiflow + interfaces are designed for use with the airvo 2 series of humidification devices.The airvo 2 device is intended for use with spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases.The airvo 2 should not be used for life support purposes, and appropriate patient monitoring must be used at all times.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 remove the load of the breathing circuit from the patient's interface.Method: the opt970 optiflow + tracheostomy direct connection interface was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is based on the information and the photograph provided by the customer, and our knowledge of our product.Results: the customer has stated that the tubing of an opt970 optiflow + tracheostomy direct connection was found damaged.Visual inspection of the provided photograph confirmed that the tubing was damaged near the 3-way connector.Conclusion: we are unable to determine the cause of the reported damage to the subject opt970 optiflow + tracheostomy direct connection.However, based on our knowledge of the product and parts of the tubing being damaged, the reported event was likely caused by the cannula being subjected to excessive force.Manufacturing controls include inspections 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 opt970 optiflow + tracheostomy direct connection interface would therefore have met the required specifications.Our user instructions that accompany the opt970 optiflow + tracheostomy direct connection interface show in pictorial format the correct placement and fitting of the cannula, including ensuring the lanyard is secured properly.The user instructions also warn: 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 + TRACHEOSTOMY INTERFACE
• Common Device Name: 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 300; irvine, CA 92618 ; 9494534002
• MDR Report Key: 14725754
• Report Number: 9611451-2022-00563
• Device Sequence Number: 20345451
• Product Code: BTT
• UDI-Device Identifier: 09420012436917
• UDI-Public: (01)09420012436917(10)2101776889(11)210827
• 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: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2022

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: OPT970
• Device Catalogue Number: OPT970
• Device Lot Number: 2101776889
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2022
• Supplement Date Received by Manufacturer: 06/27/2022
• Initial Report FDA Received Date: 06/17/2022
• Supplement Report FDA Received Date: 06/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2021
• 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
• Patient Sex: Unknown