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

Model Number OPT944

Device Problem Device Handling Problem (3265)

Patient Problem Pressure Sores (2326)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The opt944 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 opt944 nasal cannula was not returned to fisher & paykel healthcare in (b)(4).Therefore, our investigation was performed based on the information provided by the customer and our knowledge of the product.Conclusion: we were unable to confirm what caused the pressure sores on the patient's ear.However, based on our knowledge of the product, pressure sores are often a result of incorrect set up.Fisher & paykel healthcare representative offered to provide further training regarding correct fitting and set up to the customer, however it was declined.The user instructions which accompany the opt944 nasal cannula contain pictorial instructions for setting up the nasal cannula.The instructions also state that the interface is intended to be used "for delivery of humidified respiratory gases" and includes the following cautions/warnings: - 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 healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) representative that the optiflow nasal cannula opt944 caused grade 3 pressure sores above ears on a patient.There was no further 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
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: faranak gomarooni ; 173 technology drive; suite 100; irvine, CA 92618 ; 9194534000
• MDR Report Key: 7976598
• MDR Text Key: 124829594
• Report Number: 9611451-2018-00894
• 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: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/20/2018

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: OPT944
• Device Catalogue Number: OPT944
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/20/2018
• Initial Date FDA Received: 10/17/2018
• 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