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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESMED CORP F20 MASK; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

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RESMED CORP F20 MASK; VENTILATOR, NON-CONTINUOUS (RESPIRATOR) Back to Search Results
Patient Problems Aneurysm (1708); Pain (1994); Eye Burn (2523); Balance Problems (4401); Hemorrhagic Stroke (4417); Eye Pain (4467); Dry Mouth (4485); Nodule (4551)
Event Date 03/02/2019
Event Type  malfunction  
Event Description
With so much recalled i don't know what could or couldn't be contributed to what.My doctor says let's take care of you and let the attorneys worry about the recalls.But they don't know what could be or couldn't be contributed to the equipment.I am riding the silent philips dreamstation bipap train.I developed 4 nodules on my thyroid glands but they are slow growers.They aren't big enough to biopsy to see if they are cancerous yet.I hope they don't get big enough to biopsy.I don't want a needle stuck in my neck and i certainly don't want cancer.But medicare and me paying for these ultrasounds and doctor visits isn't right.Philips should be paying my medical expenses for the treatment of the thyroids.If it is or isn't cancer doesn't matter, i know it was caused by the philips dreamstation bipap machine.But along with the dreamstation they gave me a resmed f20 mask.They affect some implanted medical equipment, but they don't say which ones.I have a stent flow diverter located in vestibular v3 and v4 vertebrae arteries.I have plates and pins used to reconstruct my right wrist.I have lens implants from cataract surgery.With the resmed f20 mask i don't know if they could be the problem i am having after two cataract surgeries in (b)(6) 2023.It wasn't successful and i can't see, my eyes itch and burn and just hurt all the time.The ophthalmologist and my retina are can't find what could be causing it.If they don't know, what do i know? i am losing teeth.Dentist says dry mouth, but i have lost all my upper molars.Nothing has stopped me from losing more teeth.Medicare doesn't pay for dental, and i am in social security and co-pay poor from all my health issues.The last estimate to replace a front tooth was over (b)(6) so i just let them keep falling out.I have a respiratory problem nobody has diagnosed.But to be fair, i had a ruptured brain aneurysm and subarachnoid hemorrhage stroke in (b)(6) 2019.My neurosurgeon says none of my health issues can be related to the aneurysm because it was totally obliterated.I have no balance and can barely walk from the pain, but i also had peripheral arterial disease.It would be nice if i had some kind of an idea if the mask is somehow interfering with the stent in my head and neck.Or affecting my teeth from the strap pressure and the magnets and fillings in my teeth.The front tooth i lost was ground down and had a post inserted in my gum.I don't know what material is used for the post.I am just a patient with a whole "team" of doctors who can't figure out what is causing anything and none of them know anything about the bipap and mask recall and don't want to find out.If there is any way i can get information about what could be affected by the mask and bipap i would appreciate it.It just seems too odd to me to think it all just coincidentally happened after i started using the machine and mask.And i also use an oxygen concentrator with the bipap for supplemental oxygen.If that foam is causing problems by just being blown around with the machine, i have added additional blowing with the oxygen concentrator attached to the bipap.I just don't understand how both pieces of equipment i got were defective.How lucky can one person get.I have been told i need to see my doctor to get a prescription to exchange masks.You would think they would want me out of that mask as soon as possible.Refer to additional documents in i2k.Reference report: mw5151098.
 
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Brand Name
F20 MASK
Type of Device
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
Manufacturer (Section D)
RESMED CORP
MDR Report Key18658673
MDR Text Key335076114
Report NumberMW5151097
Device Sequence Number1
Product Code BZD
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Unknown
Type of Report Initial
Report Date 02/02/2024
1 Device was Involved in the Event
Date FDA Received02/06/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Is This a Reprocessed and Reused Single-Use Device? No
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