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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 No Audible Alarm (1019); Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The complaint pt101 airvo 2 humidifier is currently en route to fisher & paykel healthcare(f&p) (b)(4) for evaluation.We will provide a follow up report upon completion of our investigation.
 
Event Description
A healthcare facility in (b)(6) reported that the speaker of a pt101 airvo 2 humidifier was faulty.There was no patient involvement.
 
Event Description
A healthcare facility in maryland reported that the speaker of a pt101 airvo 2 humidifier was faulty.There was no patient involvement.
 
Manufacturer Narrative
(b)(4).Method: the complaint pt101 airvo 2 humidifier was not returned to fisher & paykel healthcare (f&p) for evaluation.Therefore, our investigation is based on the information provided by the customer and our knowledge of the product.Results: the customer reported that the speaker of a pt101 airvo 2 humidifier was faulty.Conclusion: as part of our ongoing product improvement initiatives, a new speaker unit has been sourced from a different supplier.The airvo 2 user manual states that the "airvo 2 is for the treatment of spontaneously breathing patients who would benefit from receiving high-flow, warmed and humidified respiratory gases" and that "the unit is not intended for life support." the user manual warns the user: - 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 check the alarm and states that "if either alarm signal is absent, do not use the unit.Contact your fisher & paykel healthcare representative.".
 
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Brand Name
AIRVO 2 HUMIDIFIER
Type of Device
AIRVO 2 HUMIDIFIER
MDR Report Key11441136
MDR Text Key245113100
Report Number9611451-2021-00255
Device Sequence Number1
Product Code BTT
UDI-Device Identifier09420012422347
UDI-Public(01)09420012422347(10)2100664208(11)181215
Combination Product (y/n)N
PMA/PMN Number
K131895
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 02/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberPT101
Device Catalogue NumberPT101
Device Lot Number2100664208
Was Device Available for Evaluation? No
Date Manufacturer Received04/12/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/15/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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