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

Model Number OPT544

Device Problem Device Handling Problem (3265)

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

Event Date 01/08/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the complaint opt544 cannula was received for evaluation at our regional office in brazil and was visually inspected.Our investigation is based on the information and photographs provided by our office.Results: visual inspection of the photographs revealed that the right side of the nasal interface had been pulled apart and was broken at the left headgear connection point.Conclusion: the most likely cause of the observed damage is overtightening of the headstrap while adjusting it.Our user instructions that accompany the opt544 illustrate the procedure for fitting the optiflow nasal cannula to a patient and state the following: - do not crush or stretch tube.The opt544 interface is shipped to the customer fully assembled.The cannula is 100% inspected by production line staff during assembly for visual defects such as cracks, tears, inclusions, discolouration and deformation.If any are found the product is discarded.Evaluated at regional office.

Event Description

A hospital in (b)(6) reported that an opt544 optiflow nasal cannula broke close to the headgear after six days of patient use.No patient consequence was reported.

• Brand Name: OPTIFLOW NASAL 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: jon stevens ; 173 technology drive; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 6327895
• MDR Text Key: 67321551
• Report Number: 9611451-2017-00093
• Device Sequence Number: 1
• Product Code: CAT
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Respiratory Therapist
• Type of Report: Initial
• Report Date: 01/16/2017

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: OPT544
• Device Catalogue Number: OPT544
• Device Lot Number: 2100026772
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2017
• Initial Date FDA Received: 02/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2016
• 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