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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD RESPIRATORY HUMIDIFIER; BTT
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FISHER & PAYKEL HEALTHCARE LTD RESPIRATORY HUMIDIFIER; BTT Back to Search Results
Model Number MR850
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Respiratory Arrest (4461)
Event Type  Injury  
Event Description
A healthcare facility in france reported via a fisher and paykel healthcare (f&p) field representative, that a tracheostomy tube was occluded due to a mucus plug.This occurred on two occasions with the same patient.The healthcare facility reported that this led to the patient having a respiratory arrest.At the time of the event respiratory humidification was being provided to the patient using a mr850 respiratory humidifier the patient required recannulation and there were no further patient consequences reported.
 
Manufacturer Narrative
(b)(4).Further information on the reported event and patient consequence was requested.The complaint mr850 respiratory humidifier was also requested to be returned to fisher & paykel healthcare (f&p) for evaluation.We will provide a follow up report upon completion of our investigation.
 
Event Description
A healthcare facility in france reported via a fisher and paykel healthcare (f&p) field representative, that a tracheostomy tube was occluded due to a mucus plug.This occurred on two occasions with the same patient.The healthcare facility reported that this led to the patient having a respiratory arrest.At the time of the event respiratory humidification was being provided to the patient using a mr850 respiratory humidifier the patient required recannulation and there were no further patient consequences reported.
 
Manufacturer Narrative
(b)(4), section d4 and h4: device 1: serial #: (b)(6) device 2: serial #: (b)(6) note: the healthcare facility did not identify which device was associated with which event.Method: the complaint mr850 respiratory humidifier was not returned to fisher & paykel healthcare in new zealand for evaluation.Our investigation is therefore based on the information provided by the customer, and our knowledge of the product.Results: the healthcare facility reported via a fisher and paykel healthcare (f&p) field representative, that a tracheostomy tube was occluded due to a mucus plug.This occurred on two occasions with the same patient.The healthcare facility reported that this led to the patient having a respiratory arrest.At the time of the event respiratory humidification was being provided to the patient using a mr850 respiratory humidifier the patient required recannulation and there were no further patient consequences reported.The healthcare facility further reported that the subject mr850 respiratory humidifier passed performance testing and was put back into service.Conclusion: based on the information provided, 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.".
 
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Brand Name
RESPIRATORY HUMIDIFIER
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
omid taheri
17400 laguna canyon road
suite 300
irvine, CA 92618
8007923912
MDR Report Key17176210
MDR Text Key317637811
Report Number9611451-2023-00570
Device Sequence Number1
Product Code BTT
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K110019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 06/13/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/21/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberMR850
Device Catalogue NumberMR850
Device Lot NumberSEE H10
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received08/14/2023
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 Number1
Treatment
DRAEGER V300 VENTILATOR; DRAEGER V300 VENTILATOR; F&P RT380 ADULT EVAQUA2 BREATHING CIRCUIT; F&P RT380 ADULT EVAQUA2 BREATHING CIRCUIT; TRACHEOSTOMY TUBE; TRACHEOSTOMY TUBE
Patient Outcome(s) Required Intervention;
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