MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD ADULT NASAL INTERFACE; CAT

Model Number OPT842

Device Problem Device Issue (2379)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/23/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The optfilow nasal interface is used to deliver humidified oxygen to patients and consists of a lightweight delivery tube 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.The complaint opt842 (size small) nasal cannula was not available for evaluation as it was contaminated and had been discarded by the customer.Further information was sought but no response was received.The customer statement that the cannula had "poor connection between the interface and the tubing" suggests that the tubing was loose where it connects to the manifold.Conclusion: without further information or a device for evaluation we cannot confirm the nature of the problem as reported by the customer.All optiflow interfaces are inspected during production for visual defects including cracks, tears, inclusions, discolouration and stretching or deformation.Any product that fails the visual inspection is disposed of.The customer also informed us that the cannulae were used for approximately two days before failing.The user instructions which accompany the opt842 show in pictorial format the correct fitting and placement of the cannula and ad vise the user to "ensure nasal cannula is sized correctly and does not create a seal in the nares".They also.Contain the following warning: appropriate patient monitoring must be used at all times.Failure to monitor the patient may result in loss of therapy, serious injury or death.

Event Description

A hospital in (b)(6) reported that an opt842 optiflow nasal cannula had "poor connection between the nasal interface and the tubing".No patient consequence was reported.

• Brand Name: ADULT NASAL INTERFACE
• Type of Device: CAT
• 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: jon stevens ; 173 technology drive; suite 100; irvine, CA 92618 ; 9194534000
• MDR Report Key: 6348262
• MDR Text Key: 67940802
• Report Number: 9611451-2017-00116
• Device Sequence Number: 1
• Product Code: CAT
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OPT842
• Device Catalogue Number: OPT842
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2017
• 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