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Our daughter ((b)(6) years old) was severely burned by her airvo 2 tubing - while receiving heated humidification throughout the night.This was the second burn that she received from this unit.The first was a month prior, very small burn, also reported to (b)(6)/company - but at this time thought it was a fluke based off of the company response.Correspondence after first (minor) burn is below: "i have not heard of this happening before, kind of surprised the tubing can get that hot.I have sent this info to our f&p rep, i would recommend not doing the vent tube cover until i hear back, that could make the tubing even hotter.I will let you know as soon as i do"; "i heard back from the f&p rep and they do not have any incidents like this on file.Do you still have the tube that burned (b)(6) leg? they are asking if we can return it to them so they can inspect it.As far as the sleeve goes, it should be fine as long as it isn't in the sleeve and under a blanket, that may create too much heat"; (b)(6) was then sent a list of questions to answer and that was the last correspondence we had regarding the first burn event.No other correspondence / recommendations or investigation into the unit was completed after this first minor burn.Every night after the first burn occurred we dressed our daughter in pajama pants because we felt safer doing this (this was not recommended and we were never told this was necessary to do to prevent burns) there was no direct skin contact when the second burn occurred.Our daughter is not covered in a blanket when sleeping, and only uses a sheet over her throughout the night.The second burn she received from the airvo 2 tubing is a 'deep second degree burn' based off of (b)(6) hospital evaluation.We are now 5 1/2 weeks since the burn and it has yet to heal completely.(b)(6) hospital indicated it could take months to heal based off of the depth of the burn.(it being a very deep injury - deep second degree burn) there are other reports that have been filed with the fda regarding the airvo 2 - incidents reporting the tubing melting (no patient injury).This unit/ tubing has now resulted in a severe injury to a child.And this tubing/ unit has burned our daughter not once but twice.There was also another burn incident caused by the airvo 2 that we found on social media (b)(6).We hope you take this seriously and the company is mandated to resolve this issue asap so that a child/ patient is not burned again by this unit/tubing.One patient injury is too many.Pictures of her injury are attached.We have yet to receive information about the product testing and it has been 5+ weeks since the burn occurred.Product was returned to the company/ sent to fisherpaykel.Fda safety report id # (b)(4).
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Additional information received from reporter on 12/2/2020 for report mw5097607.Deep second degree burn; this is a follow up regarding a report already filed by us - pertaining to a burn our (b)(6) year old daughter received by using the airvo2.We received the fisher paykel (fp) testing report back and they are reporting no problem with their device.This is very concerning, given our daughter was burned twice by this unit within 2 months of one another.We were never made aware of the risk of burns before using the airvo machine.And this risk was never mentioned, even after we reached out after (b)(6) first minor burn incident.After her first burn we were not told to take any certain/additional precautions because there was a risk of burns with this unit.Instead we were told that "they (fisher paykel) do not have any incidents like this on file." (we have included this first correspondence in a previous email) after researching we realized that this statement "do not have any incidents like this on file." was not accurate - as there are several maude reports of melted tubing and a burn.As stated many times previously - there was no direct skin contact, as (b)(6) was dressed in pajama pants nightly after the first minor burn event."direct skin contact" would imply no barrier between the tubing and skin, which was not the case when (b)(6) received her second burn.Also, the manual, in step 4, instructs the user to "connect the breathing tube clip to patient clothing," which seems rather contradictory, as the fisher paykel report is implying that direct contact with the skin still exists even with pajama pants/clothing on?) the tubing was not under a blanket, as (b)(6) only sleeps with a sheet.We would like the above m details added to the report, as it seems it has been forgotten about? it should also be noted that this was (b)(6) second burn from this unit.(we are unable to locate a maude report from this incident?) this is not an isolated incident.And there are many maude reports of tubes melting and at least one other burn incident reported.This is a unit manufactured for use during sleep.This is unit that is manufactured for all ages and people of all physical abilities to use.This is a unit that is marketed for home use.There is no way to prevent 'direct skin contact' (with pajamas on) or prevent a person from laying/resting on tubing- while sleeping.Fisher paykel is saying that a severe second degree burn was caused by laying on the tubing (for an 'extended length of time' - which the acceptable amount of time is yet to be clarified.) again, this is a unit used when sleeping.The general population does not lay completely still while sleeping.And if this is what is expected in order to use the airvo safely and not be at risk of burns - then this needs to be noted and it then significantly decreases the populations that can safely use the unit.Someone else will be injured again and we are very frustrated by the lack of action fisher and paykel is taking.The tubing from a medical device should never cause a burn of any size/degree on a child.When one sleeps they wear pajamas (and not always pants), most sleep with blankets, and many roll around when sleeping.Consumers are not aware that the above normal actions - can cause severe burns on their children when using the airvo2.We should have been told about the specific burn risks after her first minor burn, so that we could have discontinued the airvo use at that time.We should have been told that (b)(6) could sustain another burn even is she was dressed in pajama pants, uses only a sheet, or if she rolls on the tubing, for any amount of time.We are reporting this again, because children are at severe risk of burns from this unit/tubing.Again tubing used to sleep should never cause a burn on a child - especially with the precautions we were taking.Fisher paykel and the fda need to step up.Please contact me for more information and an fda update, (b)(6).Important to note, our daughter was clothed and no blanket was used.There was "not direct skin contact." fda safety report id# (b)(4).
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