MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD OPT970 OPTIFLOW + TRACHEOSTOMY DIRECT CONNECTION; 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	02/18/2023
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).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 to support the weight of the circuit and prevent the tubing being dislodged from the patient's tracheostomy.
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
Corrected data: d9 and h3 updated as device was not returned to manufacturer.(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.Additionally, a tubing clip (attaches to the patient's clothing/bedding) is provided to support the weight of the circuit and prevent the tubing from being dislodged.Method: the complaint opt970 optiflow + tracheostomy direct connection was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is based on the information provided by the customer, previous investigations of similar complaints, and our knowledge of the product.Results: the customer reported that the tubing of the optiflow + tracheostomy direct connection was damaged.Conclusion: without a photograph or the return of the device our investigation is unable to confirm the reported damage.Based on our knowledge of the product, the reported damage is likely to have been caused by the tubing being subjected to excessive force during use.Manufacturing controls include inspections during production for visual defects to the optiflow + tubing and the swivel, including cracks, tears, moulding defects, contamination, inclusions, discoloration and stretching or deformation.The optiflow + tubing is also inspected for any assembly defects, including confirmation the swivel and 3-way connector are connected with the correct engagement.Any product that fails the visual inspection is disposed of.The subject opt970 optiflow + tracheostomy direct connection would have met the required specifications.The user instructions which accompany the opt970 optiflow + tracheostomy direct connection show in pictorial format the correct placement and fitting of the connector, including ensuring the lanyard and the tubing clip are appropriately attached.The user instructions also warn: "the lanyard is designed to minimise loading and movement of the tracheostomy tube.Secure the lanyard properly to avoid accidental decannulation or airway damage." "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."."failure to use the set-up described above can compromise performance and affect patient safety.

• Brand Name: OPT970 OPTIFLOW + TRACHEOSTOMY DIRECT CONNECTION
• 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: 16606479
• Report Number: 9611451-2023-00239
• Device Sequence Number: 14969155
• Product Code: BTT
• UDI-Device Identifier: 09420012436917
• UDI-Public: (01)09420012436917(10)2101945385(11)211210
• 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): 02/22/2023

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
• Operator of Device: Health Professional
• Device Model Number: OPT970
• Device Catalogue Number: OPT970
• Device Lot Number: 2101945385
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/13/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2023
• Supplement Date Received by Manufacturer: 04/20/2023
• Initial Report FDA Received Date: 03/23/2023
• Supplement Report FDA Received Date: 04/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2021
• 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