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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD MYAIRVO 2 HUMIDIFIER
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FISHER & PAYKEL HEALTHCARE LTD MYAIRVO 2 HUMIDIFIER Back to Search Results
Model Number PT100
Device Problems No Audible Alarm (1019); No Audible Prompt/Feedback (2282)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/07/2022
Event Type  malfunction  
Event Description
A distributor in michigan reported via a fisher & paykel healthcare (f&p) field representative that the audible alarm of a pt100 myairvo 2 humidifier was not functioning.There were no reported patient consequences.
 
Manufacturer Narrative
(b)(4).The complaint pt100 myairvo 2 humidifier is currently en route to fisher & paykel healthcare (f&p) new zealand for evaluation.We will provide a follow up report upon completion of our investigation.
 
Manufacturer Narrative
(b)(4).The pt100 myairvo 2 humidifier (myairvo 2) device is an active humidifier with integrated flow generator that delivers high flow warmed and humidified respiratory gases to spontaneously breathing patients through a variety of patient interfaces.It's intended use is for the treatment of spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases.The myairvo device should not be used for life support purposes, and appropriate patient monitoring must be used at all times.The myairvo speaker is intended to provide auditory alerts to the user and auditory alarms under certain conditions.The alarm system functionality must be checked prior to each patient use.The user instructions warn "if either alarm signal is absent, do not use the unit.Contact your fisher & paykel healthcare representative".In the case of speaker failures, a speaker will typically provide a distorted, intermittent or reduced sound level before becoming completely inaudible over time.This contributes to the early detection of this fault by users.It should also be noted that in the event of a speaker failure during use, the myairvo will continue to deliver therapy as per the set parameters.For any alarm condition, the device simultaneously displays a visual alarm alongside auditory alarms and so in the absence of an audible alarm due to speaker failure, a visual alarm will still be displayed.Method: the complaint myairvo 2 was received at fisher & paykel healthcare (f&p) in new zealand.The device was performance tested and the audible alarm function was checked.Results: performance testing revealed that the audible alarm of the myairvo 2 unit was working.Conclusion: we are unable to determine what may have caused the reported failure as there was no fault found with the returned device.
 
Event Description
A distributor in michigan reported via a fisher & paykel healthcare (f&p) field representative that the audible alarm of a pt100 myairvo 2 humidifier was not functioning.There were no reported patient consequences.
 
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Brand Name
MYAIRVO 2 HUMIDIFIER
Type of Device
MYAIRVO 2 HUMIDIFIER
Manufacturer (Section D)
FISHER & PAYKEL HEALTHCARE LTD
15 maurice paykel place
east tamaki
auckland, 2013
NZ  2013
Manufacturer (Section G)
FISHER & PAYKEL HEALTHCARE LTD
15 maurice paykel place
east tamaki
auckland, 2013
NZ   2013
Manufacturer Contact
faranak gomarooni
17400 laguna canyon road
suite 300
irvine, CA 92618
9494534002
MDR Report Key14293367
MDR Text Key295496088
Report Number9611451-2022-00440
Device Sequence Number1
Product Code BTT
UDI-Device Identifier09420012422248
UDI-Public(01)09420012422248(10)2101551063(11)210316
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131895
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative,Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 04/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/05/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberPT100
Device Catalogue NumberPT100
Device Lot Number2101551063
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received05/11/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/16/2021
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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