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

Model Number OPT844

Device Problem Device Issue (2379)

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

Event Date 03/27/2016

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 cannulae have not been returned to fisher and paykel healthcare (b)(4) for evaluation.Our investigation is based on information supplied by the customer.Result: all we were told was that the cannulae were torn at the silicone part (nasal interface).Further information was sought and a request was made for the return of the complaint cannulae, however to date we have received no response.The description of events suggests that the soft silicone part of the nasal interface had been torn apart.Previous investigations into this type of damage have shown that the most likely cause is overtightening of the headstrap while adjusting it.An excessive amount of force would be required to tear the interface.Conclusion: the subject cannulae would not have passed testing on the production line in a damaged condition.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.

Event Description

A hospital in (b)(6) reported via our distributor that the 'silicone part' of two opt844 nasal cannulae was torn.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: raymond yan ; 173 technology drive; suite 100; irvine, CA 92618 ; 9194534000
• MDR Report Key: 5642803
• MDR Text Key: 44777550
• Report Number: 9611451-2016-00203
• Device Sequence Number: 1
• Product Code: CAT
• Combination Product (y/n): N
• Reporter Country Code: IS
• 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: 04/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2016
• 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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/10/2016
• 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