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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 No Audible Alarm (1019); Alarm Not Visible (1022); Infusion or Flow Problem (2964)
Patient Problem Low Oxygen Saturation (2477)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).We are in the process of obtaining further information and the alleged device for investigation.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 of an incident involving a pt101 airvo2 humidifier.A patient using the airvo2 humidifier experienced a desaturation.It was reported that the airvo2 humidifier flow rate decreased and there was no alarm.During this event, the patient's oxygen saturation level dropped and was put on a bag valve mask.The patient's oxygen saturation levels were restored after bagging and the patient was put back on to niv.No further patient consequences were reported.
 
Manufacturer Narrative
Ps323273.Section b1 report type and b2 amended due to further information received.Additional information was requested from the customer as part of the root cause analysis.The customer provided information regarding the patient's medical history relevant to this event.The patient's medical history included "seizures respiratory failure", "global developmental delay", and "polymicrogyria".The customer further reported that "patient remains on niv on a slow one way wean after the incident, however not due to the desaturation incident." results: during testing, the airvo 2 humidifier powered on and was found to be performing as expected.During the inspection, an incidental finding was that the audible alarm of the complaint airvo 2 humidifier was not working which is caused by a faulty speaker and electrical resistance testing has shown the speaker's resistance to being open circuit.A review of the airvo 2 humidifier device log did not present any evidence to suggest any issues with flow on the event date that would have triggered an alarm.Conclusion: we are unable to determine what has caused the reported event, as testing found the device to be functioning as expected and our review of the device log found no malfunction or flow issue that would have triggered an alarm.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 has visual and auditory alarms to warn operators about interruptions to patient's treatment.- prior to each patient use, ensure that the auditory alarm signal is audible by conducting the alarm system functionality check described in the alarms section.The alarm system functionality check instructs the user on how to test the alarm and states that "if either alarm signal is absent, do not use the unit.Contact your fisher & paykel healthcare representative." additionally, the user manual also warns the user: - 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.
 
Event Description
A healthcare facility in birmingham reported via a fisher & paykel healthcare (f&p) field representative a complaint involving a patient who experienced a desaturation while using a pt101 airvo2 humidifier.It was reported that the airvo2 humidifier flow rate decreased and there was no alarm.During this event, the patient's oxygen saturation level dropped and the patient was put on a bag valve mask.The patient's oxygen saturation levels were restored after bagging and the patient was put back on to niv.No further patient consequences were reported.Further information provided by the customer suggested that the patient desaturated while the hospital staff was on their way to retrieve another airvo2 humidifier to change out with the complaint device.
 
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Brand Name
AIRVO2 HUMIDIFIER
Type of Device
AIRVO2 HUMIDIFIER
MDR Report Key9313568
MDR Text Key178588474
Report Number9611451-2019-01097
Device Sequence Number1
Product Code BTT
UDI-Device Identifier09420012422354
UDI-Public(01)09420012422354(10)2100555454(11)180813
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 10/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2019
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 Number2100555454
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/17/2019
Date Manufacturer Received02/27/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/13/2018
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) Required Intervention;
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