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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AIRVO 2 HUMIDIFIER
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AIRVO 2 HUMIDIFIER Back to Search Results
Model Number PT101
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Therapeutic or Diagnostic Output Failure (3023)
Patient Problems Low Oxygen Saturation (2477); Unspecified Respiratory Problem (4464)
Event Date 07/18/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4).Fisher & paykel healthcare (f&p) is currently in the process of obtaining additional information with regards to the reported event and patient condition.We have also requested the subject device to be returned to f&p (b)(4) for investigation.We will provide an update once our investigation has been completed.
 
Event Description
A healthcare facility in (b)(6) reported that a patient experienced worsening respiratory conditions and was provided an alternative source of ventilation and transferred to the neonatal intensive care unit (nicu) following an incident where the pt101 airvo 2 humidifier shut down while in use with an opt314 optiflow junior nasal cannula.The event was discovered the following morning during the doctor's routine visit.It was further reported that the audio alarm of the subject pt101 airvo 2 humidifier was not functioning.There were no further reported patient consequences.
 
Manufacturer Narrative
(b)(4).Method: the subject pt101 airvo 2 humidifier was returned to fisher & paykel healthcare (f&p) in new zealand where it was visually inspected and performance tested.Results: visual inspection of the returned subject pt101 airvo 2 humidifier revealed no signs of external or impact damage.The unit was powered on and ran for at least three continuous hours and was found to be working correctly.The audible alarm was found to be functioning as intended, including the power out alarm.It is noted that an opt314 optiflow junior nasal cannula was used with the pt101 airvo 2 humidifier.It is also noted that the unit was discovered to have been powered off the following morning during the doctor's routine visit.Conclusion: we are unable to determine what may have caused the disruption in therapy, as there was no fault found with the returned device.It should be noted that the patient presented with several pre-existing conditions including neonatal respiratory distress.The pt101 airvo 2 humidifier is not intended for use with the opt314 optiflow junior nasal cannula.The f&p field representative has since provided the customer with further training and education on the correct use and selection of optiflow junior cannulas.The airvo 2 humidifier is designed to provide humidification therapy to spontaneously breathing patients who are not dependent on mechanical respiratory support.The airvo 2 user manual includes a table of optiflow interfaces that can be used with the airvo 2 and the following information: the unit is not intended for life support.Appropriate patient monitoring must be used at all times.Loss of therapy will occur if the power is lost.If the unit has been disconnected from the mains/utility power socket, the auditory alarm will sound for at least 120 seconds.Use continuous oxygen monitoring on patients who would desaturate significantly in the event of disruption of their oxygen supply.Use of accessories not specified by fisher & paykel healthcare could result in improper operation.The opt314 optiflow junior nasal cannula user manual provides instructions for the correct set-up, including a table specifying which junior nasal cannulas can be used with a pt101 airvo 2 humidifier.
 
Event Description
A healthcare facility in france reported that a patient with several pre-existing conditions experienced worsening respiratory conditions following an incident where the pt101 airvo 2 humidifier shut down while in use with an opt314 optiflow junior nasal cannula.The event was discovered the following morning during the doctor's routine visit.The flow was increased and the patient was transferred to the neonatal intensive care unit (nicu).It was further reported that there was no audible alarm.The patient recovered to a stable condition with no further patient consequence.
 
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Brand Name
AIRVO 2 HUMIDIFIER
Type of Device
AIRVO 2 HUMIDIFIER
MDR Report Key12375361
MDR Text Key268427491
Report Number9611451-2021-00929
Device Sequence Number1
Product Code BTT
UDI-Device Identifier09420012422286
UDI-Public(01)09420012422286(10)2100907554(11)191014
Combination Product (y/n)N
PMA/PMN Number
K131895
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Type of Report Initial,Followup
Report Date 07/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberPT101
Device Catalogue NumberPT101
Device Lot Number2100907554
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/09/2021
Date Manufacturer Received09/21/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/14/2019
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
F&P OPT314 OPTIFLOW JUNIOR NASAL CANNULA; F&P OPT314 OPTIFLOW JUNIOR NASAL CANNULA
Patient Outcome(s) Other;
Patient Age2 DA
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