MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD OPTIFLOW JUNIOR 2 CANNULA; CAT

Model Number OJR416

Device Problem Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/08/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the complaint ojr416 junior cannula was not provided for evaluation.Our investigation is based on our knowledge of the product and follow up conducted with the customer.Following receipt of this complaint, fisher & paykel healthcare (b)(6) representatives visited the hospital to ascertain what had happened and provide support.Conclusion: based on the description of events and follow up discussion with the customer.The issue seems to have been due to a lack of training of one member of staff.It appears that the cannula was not placed correctly on the face.Our representatives provided additional in-service training for hospital staff.We have not received any further complaints since this incident.The user instructions illustrate in pictorial format the correct set-up and proper use of the optiflow junior 2 cannula.They also state the following: - do not stretch the cannula on application; this may cause increased pressure to the patient's skin.If necessary, the cannula may be repositioned.

Event Description

A hospital in (b)(6) reported that the prongs of an ojr416 optiflow junior 2 nasal cannula "kept bending down and blocking off" and that the baby was desaturating.It was confirmed that there was no patient harm.

• Brand Name: OPTIFLOW JUNIOR 2 CANNULA
• 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: sharon kuruvilla ; 173 technology drive; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 6776204
• MDR Text Key: 82657860
• Report Number: 9611451-2017-00710
• Device Sequence Number: 1
• Product Code: CAT
• Combination Product (y/n): N
• Reporter Country Code: NZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OJR416
• Device Catalogue Number: OJR416
• Device Lot Number: 2100145724
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2017
• 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
• Patient Age: 4 MO