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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD AIRVO 2 HUMIDIFIER

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FISHER & PAYKEL HEALTHCARE LTD AIRVO 2 HUMIDIFIER Back to Search Results
Model Number PT101
Device Problems Device Alarm System (1012); No Audible Alarm (1019)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
A healthcare facility in belgium reported via a fisher and paykel healthcare (f&p) field representative that the audible alarm of a pt101 airvo 2 humidifier was not functioning.There was no patient consequence.
 
Manufacturer Narrative
(b)(4).The complaint pt101 airvo 2 humidifier is currently en route to fisher & paykel healthcare (f&p) for evaluation.We will provide a follow up report upon completion of investigation.
 
Manufacturer Narrative
Ps(b)(4).The pt101 airvo 2 humidifier 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 airvo 2 device should not be used for life support purposes, and appropriate patient monitoring must be used at all times.The airvo 2 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 airvo 2 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 airvo 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: during testing it was found that the pt101 airvo 2 humidifier had no audible alarm.Conclusion: we are unable to determine the cause of the failure mode in this instance.
 
Event Description
A healthcare facility in belgium reported via a fisher and paykel healthcare (f&p) field representative that the audible alarm of a pt101 airvo 2 humidifier was not functioning.There was no patient consequence.
 
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Brand Name
AIRVO 2 HUMIDIFIER
Type of Device
AIRVO 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
9494534000
MDR Report Key13884007
MDR Text Key295613858
Report Number9611451-2022-00259
Device Sequence Number1
Product Code BTT
UDI-Device Identifier09420012422286
UDI-Public(01)09420012422286(10)2101337085(11)201013
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K131895
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
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 Number2101337085
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/08/2022
Initial Date FDA Received03/24/2022
Supplement Dates Manufacturer Received05/04/2022
Supplement Dates FDA Received05/25/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/13/2020
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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