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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); Electrical /Electronic Property Problem (1198)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The complaint airvo 2 humidifier is currently en route to fisher & paykel healthcare (f&p) in (b)(6) for evaluation.We will provide a follow up report upon completion of investigation.
 
Event Description
A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that the pt101 airvo 2 humidifier speaker was faulty.There was no reported patient involvement.
 
Manufacturer Narrative
(b)(4).Method: the complaint pt101 airvo 2 humidifier was received at our fisher & paykel healthcare (f&p) in new zealand and was visually inspected and electrically tested.The device was performance tested and the audible alarm function was checked.Results: during testing it was found that the audible alarm did not function.The fault was traced to a faulty speaker and electrical resistance testing showed that the speaker's resistance was open circuit.Conclusion: as part of our ongoing product improvement initiatives, a new speaker unit has been sourced from a different supplier.The airvo 2 humidifier 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 test the alarm and states that "if either alarm signal is absent, do not use the unit.Contact your fisher & paykel healthcare representative.".
 
Event Description
A healthcare facility in canada reported via a fisher & paykel healthcare (f&p) field representative that the pt101 airvo 2 humidifier speaker was faulty.There was no reported patient involvement.
 
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Brand Name
AIRVO 2 HUMIDIFIER
Type of Device
AIRVO 2 HUMIDIFIER
MDR Report Key12140513
MDR Text Key262897882
Report Number9611451-2021-00781
Device Sequence Number1
Product Code BTT
UDI-Device Identifier09420012422347
UDI-Public(01)09420012422347(10)2100056964(11)160620
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 06/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/08/2021
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 Number2100056964
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/28/2021
Date Manufacturer Received08/03/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/20/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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