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

Model Number OPT944

Device Problems Leak/Splash (1354); Gas/Air Leak (2946)

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

Event Date 01/15/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are currently attempting to retrieve the complaint device for evaluation.We will provide a follow up report upon completion of our investigation.

Event Description

A distributor in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that the opt944 nasal cannula tubing was leaking during use.There was no patient consequences reported.

Manufacturer Narrative

(b)(4).The opt944 nasal 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 opt944 nasal cannula was received at f&p in new zealand, where it was visually inspected.Results: visual inspection of the returned cannula revealed that the tubing was pulled and stretched.Conclusion: the identified damage is most likely the result of pulling on the cannula tubing with undue force.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 setup instructions in the user instructions which accompany the opt944 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 distributor in israel reported via a fisher & paykel healthcare (f&p) field representative that the opt944 nasal cannula tubing was leaking during use.There was no patient consequences 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
• MDR Report Key: 9715391
• MDR Text Key: 183967239
• Report Number: 9611451-2020-00158
• Device Sequence Number: 1
• Product Code: CAT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 01/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OPT944
• Device Catalogue Number: OPT944
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2020
• Date Manufacturer Received: 04/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1