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

Model Number OPT942

Device Problem Device Issue (2379)

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

Event Date 10/09/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The opt942 cannula 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: the complaint opt942 cannula was not returned to fisher & paykel healthcare (fph) in (b)(4) for investigation.Our investigation is therefore based on the information provided by the hospital.Results: we were informed by the hospital that the tubing was detached from the swivel connector.This was found when the patient was moved by the caregiver.Conclusion: the damage to the complaint cannula is most likely the result of pulling on the cannula tubing with undue force.All optiflow cannulae 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 opt942 optiflow+ 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.Our optiflow production team has been notified of this failure.They have carried out an internal investigation of the manufacturing process and production staff have received additional training to ensure they are following the correct assembly procedure.The subject cannula was manufactured prior to these measures.

Event Description

A hospital in (b)(6) reported that the tubing of an opt942 optiflow+ nasal cannula had become detached from the distal connector that attaches to the breathing circuit.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; 2013 ; NZ 2013
• Manufacturer Contact: sharon kuruvilla ; 173 technology drive; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 7005422
• MDR Text Key: 92172185
• Report Number: 9611451-2017-01029
• 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: 10/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OPT942
• Device Catalogue Number: OPT942
• Device Lot Number: 2100012120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/12/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/09/2015
• 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