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

Model Number OPT942

Device Problem Device Issue (2379)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/07/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The opt942 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: the complaint cannulae were not received for evaluation as the patient had disposed of them.Our investigation is based on the information received from the customer.Results: the customer informed us that the "crinkly tubing just came disconnected from the interface to hbt connector".Conclusion: we were unable to confirm the complaint as reported by the customer as we did not receive a device or a photograph to evaluate.However, based on their comments, it is most likely that the distal connector (that connects to the breathing tube) became detached from the cannula tubing.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 the (b)(6) reported on behalf of a home patient that two opt942 nasal cannulae had broken.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: jon stevens ; 173 technology drive; suite 100; irvine, CA 92618 ; 9194534000
• MDR Report Key: 6455690
• MDR Text Key: 71582665
• Report Number: 9611451-2017-00288
• Device Sequence Number: 1
• Product Code: CAT
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Physical Therapist
• Type of Report: Initial
• Report Date: 03/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: OPT942
• Device Catalogue Number: OPT942
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2017
• 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