MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD OPTIFLOW + TRACHEOSTOMY DIRECT CONNECTION; TRACHEOSTOMY PATIENT INTERFACE

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	04/23/2024
Type of Reportable Event	Malfunction
Additional 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.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.The interface is held in place by 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 tracheostomy.A tubing clip is also provided to support the weight of the circuit and prevent the tubing from being dislodged.Optiflow + interfaces are designed for use with the airvo series humidifiers and are also compatible with the fisher & paykel healthcare (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.
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 before patient use.There was no patient involvement as the issue was found whilst the device was not in use on a patient.
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 before patient use.There was no patient involvement as the issue was found whilst the device was not in use on a patient.
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.The interface is held in place by 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 tracheostomy.A tubing clip is also provided to support the weight of the circuit and prevent the tubing from being dislodged.Optiflow + interfaces are designed for use with the airvo series humidifiers and are also compatible with the fisher & paykel healthcare (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 opt970 optiflow + tracheostomy direct connection was not returned to f&p for evaluation as the healthcare facility reported that they had discarded the subject device.Our investigation is based on the information and photograph provided by the healthcare facility, previous investigations of similar complaints, and our knowledge of the product.Results: visual inspection of the provided photograph revealed that the tubing of the opt970 optiflow + tracheostomy direct connection was damaged.There were no patient consequences/involvement reported by the healthcare facility.Conclusion: our investigation was unable to determine the cause of the observed damage to the opt970 optiflow + tracheostomy direct connection.F&p's manufacturing controls for the optiflow + tubing include inspections during production for visual defects including cracks, tears, moulding defects, contamination, inclusions, discoloration and stretching or deformation.The user instructions which accompany the opt970 optiflow + tracheostomy direct connection show in pictorial format the correct placement and fitting of the connection, including ensuring the lanyard and tubing clip are appropriately attached.The user instructions also state: "attach breathing tube clip to a secure location (e.G., clothing or bedding) to support the interface." "appropriate patient monitoring must be used at all times.Failure to monitor the patient may result in loss of therapy, serious injury or death." "do not crush or stretch tube, to prevent loss of therapy." "the lanyard is designed to minimize loading and movement of the tracheostomy tube.Secure the lanyard properly to avoid accidental decannulation or airway damage." "failure to use the set-up described above can compromise performance and affect patient safety.".

• Brand Name: OPTIFLOW + TRACHEOSTOMY DIRECT CONNECTION
• Common Device Name: TRACHEOSTOMY PATIENT INTERFACE
• 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: diego vargas banuelos ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494341005
• MDR Report Key: 19402401
• Report Number: 9611451-2024-00403
• Device Sequence Number: 18078716
• Product Code: BTT
• UDI-Device Identifier: 09420012436917
• UDI-Public: (01)09420012436917(10)2102794284(11)230926
• 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,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2024

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: 2102794284
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2024
• Supplement Date Received by Manufacturer: 07/11/2024
• Initial Report FDA Received Date: 05/27/2024
• Supplement Report FDA Received Date: 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/26/2023
• 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