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

Model Number OPT844

Device Problem Device Handling Problem (3265)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The opt844 interface is used to deliver humidified oxygen to patients.The opt844 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: the complaint opt844 nasal cannula was returned to fisher & paykel healthcare (f&p) regional office in china and was taken a photo of damaged part and was disposed of.Our investigation is based on the photo provided by the regional office and our knowledge of the product.Result: visual inspection of the photo revealed that the tubing of the opt844 was pulled apart near the manifold.It also shows the nasal prong partly disconnected from the left side of the manifold.Conclusion: the damage observed was most likely cause by the careperson pulling at the tube.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 user instructions which accompany the opt844 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 on behalf of a healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) that the tubing of an opt844 nasal cannula was damaged.There was no patient involvement.

• 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: faranak gomarooni ; 173 technology drive; suite 100; irvine, CA 92618 ; 9194534000
• MDR Report Key: 8710303
• MDR Text Key: 148555181
• Report Number: 9611451-2019-00597
• Device Sequence Number: 1
• Product Code: CAT
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/20/2019

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: OPT844
• Device Catalogue Number: OPT844
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/20/2019
• Initial Date FDA Received: 06/18/2019
• 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