MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD OPTIFLOW JUNIOR VENTILATOR KIT; BTT

Model Number RT331

Device Problem Gas/Air Leak (2946)

Patient Problem Low Oxygen Saturation (2477)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are currently in the process of finalising our investigation.We will send a follow up report upon completion of our investigation.

Event Description

A healthcare facility in the united kingdom reported, via a fisher & paykel healthcare (f&p) field representative, that the temperature probe of a rt331 optiflow junior ventilator kit was not fully inserted into the breathing circuit, causing a minor gas leak over the course of 24 hours.There was no further reported patient consequence.

Manufacturer Narrative

(b)(4).Method: the complaint rt331 optiflow junior ventilator kit was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is thus based on the information and photograph provided by the customer, our knowledge of the product, and our simulation of the set-up described by the customer.Results: visual inspection of the photograph of the sample set-up provided by the customer identified that the triangle part of the temperature probe was outside of the probe port.Leak testing with different insertion depths of the chamber temperature probe confirmed that as long as the triangle part of the temperature probe was still partially within the probe port, the circuit would pass the leak test.With the triangle part of the chamber temperature probe outside of the probe port, the leak test could not be performed as the probe would be pushed out of the port as soon as flow/pressure was applied.Conclusion: without the return of the complaint device, we are unable to determine the cause of the reported event.Based on our investigation and knowledge of the product, the reported leak was most likely due to an incorrect set-up by the user.The testing conducted with the simulated set-up confirmed that the degree of leakage that occurs with a partially inserted temperature probe would still be within the leakage specifications.All rt331 optiflow junior ventilator kit breathing circuits are visually inspected, and pressure and flow tested during production, and those that fail are rejected.The subject infant breathing circuit would have met the required specifications at the time of production.Our user instructions that accompany the rt331 optiflow junior ventilator kit show in pictorial format the correct set-up of the circuit and also state the following: "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." "visually inspect breathing sets for damage (e.G.A crushed tube or cracked connector) before use, and replace if damaged." "check all connections are tight before use." "failure to apply and use this product within the directions, transport, storage and operating conditions specified in the labelling and user instructions may impair the performance of this product or compromise safety (including potentially causing serious patient harm).".

Event Description

A healthcare facility in the (b)(6) reported, via a fisher & paykel healthcare (f&p) field representative, that the temperature probe of a rt331 optiflow junior ventilator kit was not fully inserted into the breathing circuit, causing a minor gas leak over the course of 24 hours.There was no further reported patient consequence.

• Brand Name: OPTIFLOW JUNIOR VENTILATOR KIT
• Type of Device: BTT
• 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 ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494534000
• MDR Report Key: 16943489
• MDR Text Key: 315355172
• Report Number: 9611451-2023-00439
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K020332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT331
• Device Catalogue Number: RT331
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2023
• 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: F&P AIRWAY TEMPERATURE PROBE; F&P AIRWAY TEMPERATURE PROBE; F&P HEATER WIRE ADAPTOR; F&P HEATER WIRE ADAPTOR; F&P MR850 RESPIRATORY HUMIDIFIER; F&P MR850 RESPIRATORY HUMIDIFIER; MAQUET SERVO-U VENTILATOR; MAQUET SERVO-U VENTILATOR