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

Model Number OPT970

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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

Event Date 11/09/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A distributor reported on behalf of a healthcare facility in (b)(6) via a fisher and paykel (f&p) field representative that an opt970 optiflow + tracheostomy direct connection was found damaged during use.There was no reported patient consequence.

Manufacturer Narrative

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

Event Description

A distributor reported on behalf of a healthcare facility in (b)(6) via a fisher and paykel (f&p) field representative that an opt970 optiflow + tracheostomy direct connection was found damaged during use.There was no reported patient consequence.

Manufacturer Narrative

(b)(4).The opt970 optiflow + tracheostomy direct connection interface is used to deliver humidified oxygen to patients via tracheostomy.The interface is held in place by a neck strap and also includes 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 trache.Method: the complaint opt970 optiflow + tracheostomy direct connection interface was received at fisher & paykel healthcare (f&p) in new zealand for investigation where it was visually inspected.Results: visual inspection revealed that the tubing of the complaint opt970 optiflow + tracheostomy direct connection interface was found stretched at the connector end and detached from the swivel connector.Conclusion: we are unable to deremine the cause of the reported event.However, the damage observed to the opt970 optiflow + tracheostomy direct connection interface is likely due to the tubing being pulled.All optiflow interfaces are inspected 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 interface would have met the specification at the time of production.Our user instructions that accompany the opt970 optiflow + tracheostomy direct connection interface states: - 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 in japan, via a fisher and paykel healthcare (f&p) field representative, that an opt970 optiflow + tracheostomy direct connection interface was found damaged during use.There was no reported patient consequence.

• 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 ; 173 technology drive; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 13269016
• MDR Text Key: 286253849
• Report Number: 9611451-2022-00062
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K162553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/23/2021

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
• Device Operator: Health Professional
• Device Model Number: OPT970
• Device Catalogue Number: OPT970
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/23/2021
• Initial Date FDA Received: 01/17/2022
• Supplement Dates Manufacturer Received: 03/08/2022
• Supplement Dates FDA Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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