MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD FISHER & PAYKEL HEALTHCARE; 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	10/10/2024
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 after one day of use.There was no patient consequence.
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 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.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 in china reported on behalf of a healthcare facility that the tubing of an opt970 optiflow + tracheostomy direct connection was found damaged after one day of use.There was no patient consequence.
Additional Manufacturer Narrative
(b)(4).Product background: the 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.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 opt944 optiflow + adult nasal cannula was not returned to f&p for evaluation.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 opt944 optiflow + adult nasal cannula had a tear near the 3-way connector.There were no patient consequences.Conclusion: our investigation was unable to determine the cause of the observed damage to the opt944 optiflow + adult nasal cannula.Based on our knowledge of the product the tubing was likely subjected to excessive force (include time of use, length of use, if there is evidence of stretching, note any information that might indicate where the excessive force came from - i.E., trapped under the patient while the patient was turned.).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 subject opt944 optiflow + adult nasal cannula would have met the required specifications.The user instructions which accompany the opt944 optiflow + adult nasal cannula show in pictorial format the correct placement and fitting of the cannula, including ensuring the head strap clip and the tubing clip are appropriately attached.The user instructions also state: "do not crush or stretch tube, to prevent loss of therapy." "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." "appropriate patient monitoring must be used at all times.Failure to monitor the patient may result in loss of therapy, serious injury or death." "failure to use the set-up described above can compromise performance and affect patient safety.".

• Brand Name: FISHER & PAYKEL HEALTHCARE
• 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 banuelos ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494341005
• MDR Report Key: 20636413
• Report Number: 9611451-2024-00812
• Device Sequence Number: 20699073
• Product Code: BTT
• UDI-Device Identifier: 09420012436917
• UDI-Public: (01)09420012436917(10)2102574865(11)230405
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2024

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: 2102574865
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2024
• Supplement Date Received by Manufacturer: 11/07/2024
• Initial Report FDA Received Date: 11/07/2024
• Supplement Report FDA Received Date: 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/05/2023
• 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