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

Model Number OPT944

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

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

Event Date 11/20/2021

Event Type  malfunction  

Event Description

A distributor reported on behalf of a healthcare facility in (b)(6), via a fisher & paykel healthcare (f&p) field representative, that the tubing of two opt944 optiflow + adult nasal cannulas were damaged during use.There was no reported patient consequence.

Manufacturer Narrative

(b)(4).One of the two complaint opt944 optiflow + adult nasal cannulas is currently en route to fisher & paykel healthcare (f&p) for evaluation.We will provide a follow up report upon completion of investigation.

Manufacturer Narrative

(b)(4).The opt944 interface is used to deliver humidified oxygen to patients.The opt944 consists of a lightweight delivery tube which is connected to a rigid plastic base and soft nasal prongs (nasal interface).The interface is held in place by a head 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 nares.Method: one of the two complaint opt944 optiflow + adult nasal cannulas was returned to fisher & paykel healthcare (f&p) where it was visually inspected.Results: visual inspection of the returned complaint opt944 optiflow + adult nasal cannula revealed that the tubing was detached from the swivel connector.Furthermore, the tubing was found stretched at the manifold end and the connector end.Conclusion: we are unable to determine the cause of the reported event.However, it is likely that the cause of the reported event is due to pulling of the cannula.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 cannulas would have met the specification at the time of production.The user instructions which accompany the opt944 optiflow + adult nasal cannula show in pictorial format the correct placement and fitting of the cannula and also warn: - "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 & paykel healthcare (f&p) field representative, that the tubing of two opt944 optiflow + adult nasal cannulas were damaged during use.There was no reported patient consequence.

• Brand Name: OPTIFLOW + ADULT NASAL 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 ; 9494534000
• MDR Report Key: 13066848
• MDR Text Key: 284691387
• Report Number: 9611451-2021-01481
• 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: 12/01/2021

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: OPT944
• Device Catalogue Number: OPT944
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/01/2021
• Initial Date FDA Received: 12/22/2021
• Supplement Dates Manufacturer Received: 02/09/2022
• 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