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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 Failure to Deliver (2338); Device Displays Incorrect Message (2591); No Flow (2991)
Patient Problem Low Oxygen Saturation (2477)
Event Type  Injury  
Manufacturer Narrative
(b)(4).Fisher & paykel healthcare (f&p) is currently in the process of retrieving the subject pt101 airvo 2 humidifier for evaluation.We will provide a follow up report upon completion of our investigation.
 
Event Description
A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that a pt101 airvo 2 humidifier displayed an e1 error code and stopped providing flow.The patient desaturated to 75% spo2.Alternative therapy was provided while the subject pt101 airvo 2 humidifier was replaced and the patient recovered to a stable condition.There were no further patient consequences.
 
Event Description
A healthcare facility in canada reported via a fisher & paykel healthcare (f&p) field representative that a pt101 airvo 2 humidifier displayed an e1 error code and stopped providing flow.The patient desaturated to 75% spo2 and was administered oxygen therapy via the bag-valve-mask method whilst the subject pt101 airvo 2 humidifier was replaced.The patient recovered to a stable condition.There were no further patient consequences.
 
Manufacturer Narrative
(b)(4).Method: the complaint pt101 airvo 2 humidifier was received at fisher & paykel healthcare (f&p) in new zealand where it was visually inspected, and performance tested.Results: visual inspection of the subject pt101 airvo 2 humidifier revealed no signs of external or impact damage.The unit was powered on and displayed e1 error code.Further inspection revealed there was no water ingress inside the unit; however, the blower had rusted bearings which could result in increased friction on the main rotor shaft and can affect the motor functionality.Conclusion: we are unable to determine the cause of the reported event.However, the most likely cause of the reported event is due to water ingress incurred over the lifetime of the product.It should be noted that the subject pt101 airvo 2 humidifier is over five years old.When an e1 error code is triggered, an audible alarm will sound and a visual alarm will display 'fault e1' and 'if error persists, do not use the unit'.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 instruction specifies the following information: the unit is not intended for life support.Appropriate patient monitoring must be used at all times.Use continuous oxygen monitoring on patients who would desaturate significantly in the event of disruption of their oxygen supply.Do not store or use the unit where it can fall or be pulled into water.If water has entered the unit enclosure, disconnect the power cord and discontinue use.Never operate the unit if: it has been dropped or damaged, it has a damaged power cord or plug, it has been dropped into water.
 
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Brand Name
AIRVO 2 HUMIDIFIER
Type of Device
AIRVO 2 HUMIDIFIER
MDR Report Key12178460
MDR Text Key261888504
Report Number9611451-2021-00809
Device Sequence Number1
Product Code BTT
Combination Product (y/n)N
PMA/PMN Number
K131895
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 06/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberPT101
Device Catalogue NumberPT101
Device Lot Number150831
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/28/2021
Date Manufacturer Received09/02/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/31/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
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