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

Model Number OPT844

Device Problems Connection Problem (2900); Device Handling Problem (3265)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 04/04/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The opt844 interface is used to deliver humidified oxygen to patients.The opt844 consists of a lightweight delivery tube which is connected to a rigid plastic base and soft nasal prongs (nasal interface).The interface is held in place by a head strap and also includes a lanyard which is placed around the patient's neck or attached to the patient's clothing or bedding to remove the load of the breathing circuit from the patient's nares.Method: the complaint opt844 nasal cannula was not returned to fisher & paykel healthcare (f&p) for investigation and was discarded by the customer.Our investigation is based on the photographs provided by the customer and previous knowledge of the product.Result: the visual inspection of the photographs showed no damage to opt844 connector.Conclusion: without the complaint device available for evaluation, we are unable to determined what may have caused the reported issue.The user instructions which accompany the opt844 cannula show, in pictorial format, the correct placement and fitting of the cannula and also warn: - appropriate patient monitoring must be used at all times.Failure to monitor the patient may result in loss of therapy, serious injury or death.

Event Description

A distributor in (b)(4) reported on behalf of a hospital, to fisher & paykel healthcare (f&p) field representative, that the tube of an opt844 nasal cannula easily disconnected from a 900pt501 airvo heated breathing tube during set up.There was no patient involvement.

Event Description

A hospital in japan reported via our distributor to a fisher & paykel healthcare (f&p) field representative, that the tube of an opt844 nasal cannula detached from the manifold after three days of use.No patient consequence was reported.

Manufacturer Narrative

(b)(4).The opt844 interface is used to deliver humidified oxygen to patients.The opt844 consists of a lightweight delivery tube which is connected to a rigid plastic base and soft nasal prongs (nasal interface).The interface is held in place by a head strap and also includes a lanyard which is placed around the patient's neck or attached to the patient's clothing or bedding to remove the load of the breathing circuit from the patient's nares.Method: the complaint opt844 nasal cannula was received at fisher & paykel healthcare (f&p) in new zealand for evaluation.Our investigation is based on the visual assessment of the device and our knowledge of the product.Result: visual inspection of the device revealed that the tubing of the opt844 was torn and disconnected from the manifold.Conclusion: the damage observed was most likely caused by the care person or the patient pulling at the tubing.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.Subject opt844 nasal canula would have met the required specification at the time of production.The user instructions which accompany the opt844 cannula show in pictorial format the correct placement and fitting of the cannula and also warn: - appropriate patient monitoring must be used at all times.Failure to monitor the patient may result in loss of therapy, serious injury or death.- do not crush or stretch tube.

• 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: 8630407
• MDR Text Key: 146098609
• Report Number: 9611451-2019-00513
• 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: 04/18/2019

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: OPT844
• Device Catalogue Number: OPT844
• Device Lot Number: 2100647863
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2019
• Initial Date Manufacturer Received: 04/22/2019
• Initial Date FDA Received: 05/21/2019
• Supplement Dates Manufacturer Received: 05/24/2019
• Supplement Dates FDA Received: 06/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: F&P 900PT501 AIRVO HEATED BREATHING TUBE; F&P MR850 HUMIDIFIER