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

Model Number OPT946

Device Problem Device Issue (2379)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are in the process of obtaining a complaint cannula for evaluation.We will provide a follow up report upon completion of our investigation.

Event Description

A hospital in (b)(6) reported that the tubing of the opt946 nasal cannula is disconnecting from the distal connector that attaches to the breathing circuit.No specific incident details were reported.

Manufacturer Narrative

(b)(4).The opt946 interface is used to deliver humidified oxygen to patients and consists of a lightweight delivery tube connected to a rigid plastic base and soft nasal prongs (nasal interface).The interface is held in place by a head strap and features a head strap clip which works in tandem with the tubing clip (attaches to the patient's clothing/bedding) to support the weight of the circuit and prevent the cannula being dislodged.Method: no complaint cannula was received, however 86 sealed, unused cannulae were returned to fisher & paykel healthcare for evaluation.The unused samples were visually inspected and checked for defects.Results: visual inspection of the unused cannulae revealed no visible defects.Five of the unused cannulae were removed from the packaging and more closely inspected.No visible damage was found and it was not possible to detach the tubing from the swivel connectors.The swivels were found to be operational.Conclusion: we were unable to confirm the complaint as reported by the customer as no defects were found with the returned samples.All optiflow interfaces are inspected during production for visual defects including cracks, tears, inclusions, discolouration and stretching or deformation.Any product that fails the visual inspection is disposed of.The setup instructions in the user instructions which accompany the opt900 series nasal cannula include the following steps: - ensure head strap clip is attached, to prevent cannula from being pulled out of the nares.- cannula can become unattached if not used with the head strap clip.- attach tubing clip to clothing/bedding to prevent cannula from pulling off face.The user instructions also contain the following warnings/cautions: - do not crush or stretch tube, to prevent loss of therapy.- failure to use the set-up described above can compromise performance and affect patient safety.

Event Description

A hospital in (b)(6) reported that the tubing of the opt946 nasal cannula is disconnecting from the distal connector that attaches to the breathing circuit.No specific incident details were 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: 6137286
• MDR Text Key: 61191865
• Report Number: 9611451-2016-00818
• Device Sequence Number: 1
• Product Code: CAT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Respiratory Therapist
• Type of Report: Initial,Followup
• Report Date: 11/01/2016

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: OPT946
• Device Catalogue Number: OPT946
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2016
• Initial Date FDA Received: 11/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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