MAUDE Adverse Event Report: RESPIRATORY HUMIDIFIER; BTT

Model Number MR850

Device Problems Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Airway Obstruction (1699); Cardiac Arrest (1762)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The complaint mr850 respiratory humidifier is currently en route to fisher & paykel healthcare (f&p) for evaluation to determine the involvement of our product in the reported event.We will provide a follow-up report upon completion of our investigation.

Event Description

A healthcare facility in (b)(6) reported that a patient had an obstruction of the tracheal probe due to a "mucus block".The patient was setup on a mr850 respiratory humidifier system at the time of the event.There were no further reported patient consequences.

Manufacturer Narrative

(b)(4).Method: the complaint (b)(4) respiratory humidifier was not returned to fisher & paykel healthcare in new zealand for evaluation.At least three attempts were made to retrieve additional information from the customer.Some information was able to be received.Our investigation is thus based on the information provided by the customer, and our knowledge of the product.Results: the customer initially reported that the patient had an obstruction of a tracheal probe due to a "mucus block" while using the mr850 respiratory humidifier.The customer also reported that the patient experienced acute respiratory distress with significant desaturation which required the emergency intubation.The patient subsequently experienced a cardiac arrest.The patient has now recovered.The customer further noted that the cardiac arrest experienced by the patient did not occur during use on fisher & paykel healthcare devices.Conclusion: without the complaint device, we were unable to determine the cause of the reported event.The mr850 respiratory humidifier has several mechanisms to ensure that that adequate humidity is provided to the patient.As per our user instruction, mr850 invasive mode is for use with patients whose upper airways have been bypassed by either a tracheotomy or endotracheal tube.The mr850 respiratory humidifier defaults to invasive mode when the device is first turned on.The mr850 respiratory humidifier features an audible and visual alarm which alerts the user if the displayed temperature exceeds 41°c, or if the airway temperature exceeds 43°c and immediately disables the heater-wire and the heater-plate.During use, the mr850 also features a visual low temperature warning which alerts the user if the displayed temperature drops below 35.5°c for 25 seconds.This warning will alert the user that low humidity is being delivered to the patient.If the temperature continues to remain below 35.5°c, an audible alarm will also be activated.If during operation, the airway temperature decreases below 29.5 °c, a visible and audible low temperature alarm will be activated immediately.The mr850 also features a water out visual and audio alarm which will trigger if there is no water present in the water chamber.The user instructions which accompany the mr850 respiratory humidifier states: - "ensure that invasive mode is set for patients that have bypassed airways." - "ensure appropriate ventilator and/or patient monitor alarms are set, connections are tight and a leak test is completed before use." the user instructions which accompany the rt380 evaqua2 adult breathing circuit states: - ensure there is a water supply connected to the chamber and that water is present within the chamber.".

Event Description

A healthcare facility in france reported that a patient had an obstruction of the tracheal probe due to a "mucus block".The patient was setup on a mr850 respiratory humidifier system at the time of the event.The healthcare facility alleged that mr850 system did not provide adequate humidity.The patient experienced a cardiac arrest, but fully recovered.There were no further reported patient consequences.

• Brand Name: RESPIRATORY HUMIDIFIER
• Type of Device: BTT
• MDR Report Key: 9876216
• MDR Text Key: 187861235
• Report Number: 9611451-2020-00229
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• PMA/PMN Number: K073706
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 02/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MR850
• Device Catalogue Number: MR850
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: F&P 900MR805 HEATER WIRE ADAPTER; F&P 900MR869 TEMPERATURE/FLOW PROBE; F&P RT380 ADULT BREATHING CIRCUIT; MEDTRONIC 7.5MM INTUBATION PROBE; TELEFLEX CORRUGATED CONNECTION 10CM
• Patient Outcome(s): Other