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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 Device Emits Odor (1425); Sparking (2595)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The complaint pt101 airvo 2 humidifier and plug are currently en route to fisher & paykel healthcare (f&p) for evaluation to determine if our product 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 the plug of a pt101 airvo 2 humidifier made a spark at the ac outlet and a burning smell was noted when the plug was plugged in.There was no patient involvement.
 
Manufacturer Narrative
(b)(4).Method: the complaint airvo humidifier was not received at fisher & paykel healthcare (f&p) for evaluation.Investigation is thus based on information provided by the customer and our knowledge of the product.Results: the customer reported that the plug of a pt101 airvo 2 humidifier made a spark at the ac outlet and a burning smell was noted when the plug was plugged in.Conclusion: without the complaint device, we are unable to determine what caused the reported failure.The airvo 2 humidifier is designed to the electrical safety standards, iec 60601-1 and can/csa-c22.2 no.60601-1.The user instructions that accompany the airvo 2 humidifier include the following warning: "never operate the unit if it has a damaged power cord or plug" "avoid unnecessary removal of the power cord from the rear of the device.If removal is necessary, hold the connector during removal.Avoid pulling on the power cord.".
 
Event Description
A healthcare facility in canada reported via a fisher & paykel healthcare (f&p) field representative that the plug of a pt101 airvo 2 humidifier made a spark at the ac outlet and a burning smell was noted when the plug was plugged in.There was no patient involvement.
 
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Brand Name
AIRVO 2 HUMIDIFIER
Type of Device
AIRVO 2 HUMIDIFIER
MDR Report Key9794420
MDR Text Key187407262
Report Number9611451-2020-00241
Device Sequence Number1
Product Code BTT
UDI-Device Identifier09420012422347
UDI-Public(01)09420012422347(10)2100207376(11)170502
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 02/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/05/2020
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 Number2100207376
Was Device Available for Evaluation? Yes
Date Manufacturer Received06/16/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/02/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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