MAUDE Adverse Event Report: ADULT NASAL INTERFACE; BTT

Model Number OPT944

Device Problems Disconnection (1171); Detachment of Device or Device Component (2907)

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

Event Date 09/18/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are currently in the process of obtaining additional information from the customer for evaluation.We will provide a follow-up report upon completion of our investigation.

Event Description

A distributor in japan reported on behalf of a healthcare facility, via a fisher & paykel healthcare (f&p) field representative, that the opt944 nasal cannula tubing disconnected during patient use.There was no reported patient consequence.

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 that 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: the complaint opt944 optiflow adult nasal cannula was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is thus based on the information provided by the customer, previous investigations of similar complaints, and our knowledge on the product.Result: the customer reported that the opt944 optiflow adult nasal cannula tubing disconnected from the swivel connector.Conclusion: however, without the complaint device we were unable to determine the cause of the reported event.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 opt944 optiflow adult nasal cannula would have met the required 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.".

Event Description

A distributor in japan reported on behalf of a healthcare facility, via a fisher & paykel healthcare (f&p) field representative, that the opt944 optiflow adult nasal cannula tubing disconnected during patient use.There was no reported patient consequence.

• Brand Name: ADULT NASAL INTERFACE
• Type of Device: BTT
• MDR Report Key: 10720598
• MDR Text Key: 214151488
• Report Number: 9611451-2020-00925
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012429117
• UDI-Public: (01)09420012429117(10)2101062318(11)200401
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 09/25/2020

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: 2101062318
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/25/2020
• Initial Date FDA Received: 10/22/2020
• Supplement Dates Manufacturer Received: 11/05/2020
• Supplement Dates FDA Received: 12/01/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2020
• 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