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

Model Number OPT970

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 01/03/2023

Event Type  malfunction  

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 to support the weight of the circuit and prevent the tubing being dislodged from the patient's tracheostomy.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.

Event Description

A distributor reported on behalf of a healthcare facility that the tubing of an opt970 optiflow + tracheostomy direct connection had detached from the 3-way connector.There was no patient consequence.

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 head strap and features a head strap clip 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 opt970 optiflow + tracheostomy direct connection was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is based on the information and photograph provided by the customer, previous investigations of similar complaints, and our knowledge of the product.Results: visual inspection of the provided photograph revealed the tubing of the opt970 optiflow + tracheostomy direct connection had detached from the 3-way connector.Conclusion: our investigation was unable to determine the cause of the observed damage to the opt970 optiflow + tracheostomy direct connection.However, based on our knowledge of the product and the type of damage observed, 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.".

Event Description

A distributor reported on behalf of a healthcare facility that the tubing of an opt970 optiflow + tracheostomy direct connection had detached from the 3-way connector.There was no patient consequence.

• Brand Name: OPTIFLOW + TRACHEOSTOMY INTERFACE
• 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 ; 173 technology drive; suite 100; irvine, CA 92618 ; 9494534002
• MDR Report Key: 16280246
• MDR Text Key: 308632708
• Report Number: 9611451-2023-00062
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K162553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OPT970
• Device Catalogue Number: OPT970
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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