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

Model Number OPT970

Device Problem Break (1069)

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

Event Date 06/18/2022

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 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.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 in china that the tubing of a opt970 optiflow + tracheostomy direct connection was damaged during use.There were no reported patient consequences.

Manufacturer Narrative

(b)(4).Section b5 was corrected from initial report from "there was no reported patient involvement" to there were no reported patient consequences.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 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: visual inspection of the provided photograph revealed that some of the tubing of the opt970 optiflow + tracheostomy direct connection was damaged and covered with adhesive tape.Conclusion: our investigation was unable to determine the cause of the observed damage to the subject opt970 optiflow + tracheostomy direct connection.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 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.

Event Description

A distributor reported on behalf of a healthcare facility in china that the tubing of a opt970 optiflow + tracheostomy direct connection was damaged during use.There were no reported patient consequences.

• Brand Name: OPTIFLOW+ TRACHEOSTOMY DIRECT CONNECTION
• 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 ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494534000
• MDR Report Key: 14881568
• MDR Text Key: 296478739
• Report Number: 9611451-2022-00582
• 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,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2022
• 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?: No
• Date Manufacturer Received: 08/23/2022
• 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