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

Model Number OPT970

Device Problems Break (1069); Material Split, Cut or Torn (4008)

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

Event Date 04/14/2022

Event Type  malfunction  

Event Description

A distributor reported on behalf of a healthcare facility in (b)(4) that the tubing of a opt970 optiflow + tracheostomy direct connection was damaged during use.There were no patient consequences.

Manufacturer Narrative

Fisher and paykel reference: (b)(4).We are currently in the process of completing our investigation.We will provide a follow up report upon completion of investigation.

Event Description

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

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 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 shows the tubing is damaged near the tracheostomy connector.Conclusion: we are unable to determine the cause of the reported event.However, based on our knowledge of the product it was likely caused by the cannula being subjected to excessive force.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.

• 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 ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494534000
• MDR Report Key: 14275164
• MDR Text Key: 295132765
• Report Number: 9611451-2022-00427
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012436917
• UDI-Public: (01)09420012436917(10)2101609111(11)210423
• 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: 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2022
• 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
• Device Lot Number: 2101609111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2021
• 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