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 03/29/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the complaint opt544 cannula was received for evaluation and was visually inspected.Results: the visual inspection revealed that the right side of the nasal interface had been pulled apart.Conclusion: the most likely cause of the reported fault 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.

Event Description

A hospital in (b)(6) reported that the tubing of an opt544 optiflow nasal cannula became damaged while the headstrap was being adjusted.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: raymond yan ; 173 technology drive; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 5607142
• MDR Text Key: 43610219
• Report Number: 9611451-2016-00174
• Device Sequence Number: 1
• Product Code: CAT
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 03/30/2016

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: 150204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2016
• Initial Date Manufacturer Received: 03/30/2016
• Initial Date FDA Received: 04/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2015
• 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