MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD NEONATAL NONINVASIVE SINGLE HEATED CIRCUIT KIT; BZE

Model Number 950N40

Device Problems Melted (1385); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

A healthcare facility in netherlands reported that the inspiratory limb of an 950n40 neonatal optiflow junior heated circuit had melted.It was also reported that the flow of the blender equipped with two flow meters has been switched off while the humidifier was still on.The healthcare facility further reported that the circuit was placed underneath two pillows and the patient's mother slept on them.There was no patient involvement as the issue was found whilst the device was not in use on a patient.

Manufacturer Narrative

(b)(4).Section g4, pma/510(k) number: the 950n40 neonatal optiflow junior heated circuit kit is not sold in the united states of america (usa) but instead a similar product, (b)(4)optiflow junior heated circuit kit is sold in the usa.Therefore, the 510(k) number for (b)(4) has been used under section g4.The f&p (b)(4) neonatal optiflow junior heated circuit kit is an accessory to the f&p 950 respiratory humidifier.It is intended for delivery of heated humidified respiratory gases to neonatal, infant and child patients, within the limits of its started technical specifications.Method: the complaint (b)(4) optiflow junior heated circuit kit was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is based on the information and picture provided by the customer and our knowledge of the product.Results: inspection of the picture provided confirmed that the inspiratory tubing of a (b)(4) optiflow junior heated circuit kit has melted.The customer also reported that the blender equipped with two flow meters were switched off while the humidifier was running at the time of the reported event (the recommended operating flow range is 0.5-36l/min on the user instructions).It was further reported that the circuit was covered by two pillows and the mother of the patient slept on them.The user instructions that accompany the subjected device cautions not to cover the circuit with materials such as bed linen, pillows, or towels as this could lead to a skin burn.Conclusion: based on the information provided by the customer and our knowledge of the product, the cause of the damage to the inspiratory limb of the 950n40 neonatal optiflow junior heated circuit kit may be due to the tubing being covered with a material and /or being under compressive load for a considerable length of time, combined with the breathing tube continuing to be operated with insufficient gas flow.All heated breathing tubes as part of the (b)(4) neonatal optiflow junior heated circuit kit are visually inspected and undergo functional tests as part of production.The heater wires are 100% visually inspected using a camera system.The heater wires are also tested for resistance, continuity, polarity, and pitch during production.Additionally, the tubing strength is tested under load.The heated breathing tube (hbt) is designed to ensure that the surface temperature does not exceed 44ºc as per iso 80601-2-74:2021 medical electrical equipment.The tubing will only reach the softening point if it is covered for a prolonged time and heat is no longer able to dissipate away from the tube.Compression alone would not cause the tubing to reach the softening point.The key factors which determine whether the heat is retained in the affected area leading to softening are: -the gas flow rate through the tube (e.G., cessation of therapy and flow while leaving the tube and humidifier powered and operating prevents the dissipation of heat) -the surface area of the hbt covered by an object - the duration of time the hbt is covered - the insulating properties of the object covering the hbt (i.E., higher thermal coefficient would allow less heat to dissipate).The 950n40 neonatal optiflow junior heated circuit kit user instructions include the following technical specifications: - operating flow range for the nasal high flow therapy is 0.5-36 l/min.The user instructions that accompany the (b)(4) neonatal optiflow junior heated circuit kit contains the following caution: do not cover the circuit with materials such as towels, pillows, or bed linen.Failure to comply may result in skin burn.Also, the user instructions that accompany the (b)(4) neonatal optiflow junior heated circuit kit warns the user: ensure there is gas flow through the tubing before connecting to a patient.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.Do not crush, stretch, or milk the tubing.Set appropriate ventilator or flow source alarms to monitor therapy delivery.

• Brand Name: NEONATAL NONINVASIVE SINGLE HEATED CIRCUIT KIT
• Type of Device: BZE
• 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: omid taheri ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 8007923912
• MDR Report Key: 18859375
• MDR Text Key: 337867691
• Report Number: 9611451-2024-00157
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: 220703
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 950N40
• Device Catalogue Number: 950N40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 950 RESPIRATORY HUMIDIFIER