MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD ADULT OPTIFLOW HEATED CIRCUIT; BZE

Model Number 950A40

Device Problems Disconnection (1171); Use of Device Problem (1670)

Patient Problems Dyspnea (1816); Low Oxygen Saturation (2477)

Event Date 10/14/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The f&p 950a40 adult optiflow heated circuit kit is not sold in the usa but it is similar to a product which is sold in the usa.The 510(k) for that product is k122432.Method: the complaint 950a40 circuit was not returned to fisher & paykel healthcare (f&p) in (b)(6) for evaluation.Our investigation is thus based on the information provided by the customer and our knowledge of the product.Results: the customer reported that the dry line from the 950a40 circuit disconnected from the drager ventilator.It was also reported that the drager ventilator did not generate an alarm.The spontaneously breathing patient was receiving high flow therapy via nasal cannula.The customer noted that the dry line likely disconnected from the ventilator when it was subject to tension during adjustment of the patient's seating position.Conclusion: without the complaint device, we are unable to determine the cause of the reported disconnection of the dry line from the ventilator.Based on the information provided by the customer, it is likely that the disconnection was due to the user causing the dry line to be subject to tension.The user instructions which accompany the f&p 950a40 adult optiflow heated circuit kit contains the following warning: "appropriate patient monitoring (e.G.Oxygen saturation) must be used at all times.Failure to monitor the patient (e.G.In the event of an interruption to gas flow) may result in serious harm or death." further statements in the user instructions include: "set appropriate ventilator or flow source alarms to monitor therapy delivery." "do not crush, stretch, or milk the tubing." "ensure there is gas flow through the tubing before connecting to a patient" "check all connections are tight before use.".

Event Description

A healthcare facility in (b)(6) reported, via a fisher & paykel healthcare (f&p) field representative, that the dry line of a f&p 950a40 adult optiflow heated circuit kit disconnected from the drager c500 ventilator after 6 days of use.It was noted that the drager ventilator did not generate an alarm.It was further reported that the dry line likely disconnected from the ventilator when it was subject to tension during adjustment of the patient's seating position.The customer noted that the (b)(6) year-old patient experienced dyspnoea and desaturated for approximately 30 minutes up to 89% spo2 levels.The patient is currently in a stable condition.After the reported event, the customer continued to use the subject device for 6 days with no further issues reported.

• Brand Name: ADULT OPTIFLOW HEATED CIRCUIT
• Type of Device: BZE
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 10833754
• MDR Text Key: 216108652
• Report Number: 9611451-2020-00992
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 950A40
• Device Catalogue Number: 950A40
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/14/2020
• 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
• Treatment: DRAGER C500 VENTILATOR; F&P 950 RESPIRATORY HUMIDIFIER
• Patient Age: 73 YR