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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AIRVO2 HUMIDIFIER
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AIRVO2 HUMIDIFIER Back to Search Results
Model Number PT101
Device Problems Device Displays Incorrect Message (2591); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Low Oxygen Saturation (2477)
Event Date 02/09/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4).We are in the process of obtaining further information from the customer to determine if pt101 airvo 2 humidifier caused or contributed to the reported event.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 patient using the pt101 airvo 2 humidifier desaturated to 60% spo2 following an incident where the airvo 2 humidifier displayed error code e146.On (b)(6) 2021 it was further reported that the patient was provided manual ventilation using a bag valve mask.The patient then experienced an anxiety attack and the hospital reported that this resulted in an increased respiratory rate and decreasing oxygen saturation.The patient was then intubated and placed on a ventilator.Following the intubation, the patient was on ventilator support for four days before the withdrawal of life support on (b)(6) 2021.
 
Event Description
A healthcare facility in indiana reported, via a fisher & paykel healthcare (f&p) field representative, that a covid-19 patient who had been using the pt101 airvo 2 humidifier & 900pt561 heated breathing tube for twenty four hours , desaturated to 60% spo2 following an incident where the airvo 2 humidifier displayed error code e146.On 2 march 2021 it was further reported that the patient was provided manual ventilation using a bag valve mask.It was also reported that the patient experienced an anxiety attack and this resulted in an increased respiratory rate and decreasing oxygen saturation.The patient was then intubated and placed on a ventilator.Further information regarding patient status was requested and it was reported that the patient deceased on (b)(6) 2021 following the withdrawal of life support.The subject airvo 2 humidifier was set up with an alternative 900pt561 breathing tube by the hospital biomedical and it was reported that the airvo 2 unit operated for over 30 hours of continuous use with no error codes.
 
Manufacturer Narrative
(b)(4).Method:the complaint pt101 airvo 2 humidifier was not returned to fisher & paykel healthcare (f&p) for evaluation.Also, due to the current outbreak of coronavirus and the ongoing risk of infection the 900pt561 heated breathing tube was discarded at the hospital and was not available for investigation.Further information was requested, however limited information was provided with regards to the reported event.Our investigation is thus based on the information provided by the customer and our knowledge of the product.Results: the customer reported that a covid-19 patient who had been using the pt101 airvo 2 humidifier & 900pt561 heated breathing tube for twenty four hours , desaturated to 60% spo2 following an incident where the airvo 2 humidifier displayed error code e146.The e146 error code is triggered to prompt the user to restart the device or replace the heated breathing tube if the fault persists.On 2 march 2021 it was further reported that the patient was provided manual ventilation using a bag valve mask.It was also reported that the patient experienced an anxiety attack and this resulted in an increased respiratory rate and decreasing oxygen saturation.The patient was then intubated and placed on a ventilator.Further information regarding patient status was requested and it was reported that the patient deceased on (b)(6) 2021 following the withdrawal of life support.The subject airvo 2 humidifier was set up with an alternative 900pt561 breathing tube by the hospital biomedical and it was reported that the airvo 2 unit operated for over 30 hours of continuous use with no error codes.Conclusion: without the return of the subject devices, we are unable to conclusively determine what caused the reported event.It was reported that the subject pt101 airvo 2 humidifier and 900pt561 heated breathing tube operated for twenty four hours with no issues prior to the reported incident.It should also be noted that the patient was covid-19 positive.All 900pt561 circuits are tested for connectivity and electrical continuity during production and those that fail are rejected.The subject 900pt561 heated breathing tube would have met the required specification at the time of production.The pt101 airvo2 humidifier user manual states that the "airvo is for the treatment of spontaneously breathing patients who would benefit from receiving high-flow, warmed and humidified respiratory gases" and "use continuous oxygen monitoring on patients who would desaturate significantly in the event of disruption to their oxygen supply".The airvo2 user manual also states following warnings: the unit is not intended for life support.Appropriate patient monitoring must be used at all times.Loss of therapy will occur if power is lost.Never operate the unit if: the hbt has been damaged with holes, tears or kinks.It is not working properly.Do not block the flow of the air through the unit and hbt.The user instructions that accompany the 900pt561 heated breathing tube also state the following: never operate the unit if the breathing tube has been damaged with holes, tears or kinks.
 
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Brand Name
AIRVO2 HUMIDIFIER
Type of Device
AIRVO2 HUMIDIFIER
MDR Report Key11600185
MDR Text Key243335868
Report Number9611451-2021-00332
Device Sequence Number1
Product Code BTT
UDI-Device Identifier09420012422347
UDI-Public(01)09420012422347(10)2100064824(11)160718
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,health
Type of Report Initial,Followup
Report Date 03/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/31/2021
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 Number2100064824
Was Device Available for Evaluation? No
Date Manufacturer Received05/05/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/18/2016
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
AMBU BAG.; AMBU BAG.; F&P 900PT561 HEATED BREATHING TUBE.; F&P 900PT561 HEATED BREATHING TUBE.; V60 BIPAP VENTILATOR.; V60 BIPAP VENTILATOR.; AMBU BAG; F&P 900PT561 HEATED BREATHING TUBE; V60 BIPAP VENTILATOR
Patient Outcome(s) Death; Required Intervention;
Patient Age73 YR
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