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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS / RESPIRONICS, INC. REMSTAR AUTO; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

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PHILIPS / RESPIRONICS, INC. REMSTAR AUTO; VENTILATOR, NON-CONTINUOUS (RESPIRATOR) Back to Search Results
Model Number 1007381
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Bacterial Infection (1735); Chest Pain (1776); Headache (1880); Hypersensitivity/Allergic reaction (1907); Myocardial Infarction (1969); Pain (1994); Sneezing (2251); Diaphoresis (2452); Cough (4457); Unspecified Respiratory Problem (4464); Renal Impairment (4499)
Event Date 01/01/2019
Event Type  Injury  
Event Description
For the past several years, i have experienced ever-increasing symptoms of poor health.Even though i was normally a fit person who watches what he eats and works out at least an hour per day 5 days a week, 1 suffered through increasing symptoms of severe allergies and now, other reported health issues have surfaced.I first tried to treat these issues with otc meds, but with poor or no results.There was always a suspicion on my part that my cpap could be the problem.I upped my cleaning procedures and also purchased 2 popular and expensive cpap cleaning machines.I also called respironics in mid 2020 to ask if other pts had experienced similar symptoms.They said "no" and that i should clean regularly (which i already did) and to be sure to use the humidifier on the device.Note: i was first diagnosed with severe sleep apnea sometime in the early 2000's through doctor (b)(6).Through doctor prescription, i received my philips respironics remstar auto cpap machine.My insurance paid for the machine.I called respironics again in early 2021, and again received the reply that my problems were not a result of the cpap.By mid 2021, i was so miserable from every day symptoms affecting my sinuses, eyes and nose with almost constant sneezing, congestion, and nasal drip, that i would easily go through a full box of tissues a day.I was experiencing-headaches, upper airway irritation, difficulty breathing, a cough, chest pressure, and sinus infections.It was difficult and sometimes impossible to leave the house.Coincidently in mid-summer 2021, i also started to notice right side chest and arm pain whenever i exercised or exerted myself in daily chores.This of course.Greatly concerned me and i determined i had to see a doctor.Early august was the soonest i could get an appointment at the (b)(6), and i went to see if i could get some remedy to ease my suffering.I also questioned my doctor whether my cpap could be causing my problems and perhaps if it should be replaced.The doctor said she didn't know if the cpap caused my issues and that there was currently a shortage of new cpaps making the waiting time to get a replacement difficult.She also stated that my right chest and arm pain was most likely not heart or lung related and would likely -subside on its own.She treated me for allergies with prescription- meds, and these turned out to have little to no effect.She also conducted a series of blood tests to try and shed light on my other issues.Several days later, she advised me that my blood tests showed i now had diminished kidney function which would need to be addressed.Shortly after my first doctor visit, i (b)(6) respironics, and discovered that there were cpap recalls due to other patients having similar issues to mine.I called philips and a short-fused receptionist told me again that my cpap was not one on their list and that my problems were not related to my cpap.Nevertheless, i immediately stopped using my respironics cpap even though i had no suitable substitute to treat my sleep apnea.Within a matter of days, my allergy symptoms began to clear up and within a couple of weeks were almost completely gone.What a miraculous relief that was.However, my chest pain was ever-increasingly worse each day such that i felt i had to have a follow-up doctor visit.I could no longer exercise without severe pain.On (b)(6) 2021, my dr visit (b)(6) was to address 4 issues: update my "allergy" problems which had completely cleared up by now since i stopped using my respironics cpap; get a prescription for a new cpap.This would now require a new 2-day sleep study.It was again emphasized to me that new cpaps were difficult to get by prescription because of the shortage due to covid issues causing shortages and, of course, the now major issue of recalls.Note: eventually in november, my sleep apnea was so troublesome, and it appeared it would take too long for a prescription/insurance replacement, that i could not wait any longer and i had to use credit card debt to purchase my own (b)(6) machine which had increased in price by (b)(6) just in the short time i had been looking.) address the process of how to improve my diminished kidney function.This would be attempted by eliminating certain medications and foods from my diet.Several series of blood test would also be necessary to monitor the progress and are still ongoing.Finally, and perhaps most importantly, to address my very painful and activity limiting right-side chest, shoulder, arm, back, neck, and head pain.I then underwent a series of heart-related tests over the next several weeks consisting of ekg tests, heart stress tests, echo chamber test, x-rays, and ct scan.Unfortunately, none of these showed any heart problems and it was concluded that my heart and lungs were ok and still strong.I had another follow-up visit with my doctor (b)(6) on (b)(6) 2021 to discuss these results and continue a course of action.Because my chest pain was right-side only, my doctor therefore continued to explore other causes such as acid reflux and musculoskeletal injury which might be the cause.The very next day on (b)(6) 2021, i had my heart attack.It started as a normal day and i was simply walking up to my workshop.As i got to my workshop, i was already in so much pain, that i determined i needed to sit down and rest, which was my procedure to usually get my blood-pressure down and allow the pain to subside.However, this time the pain did not go away and now i was short of breath, sweating, and the pain had now included the left side of my chest.It was so painful and my chest felt as if it would explode.I was transported by ambulance to (b)(6) (2 hours away) where in the emergency room they confirmed i had a heart attack and i "would be going nowhere that night".In the hospital, my cardiologist performed an angiogram/cardiac catheterization procedure and inserted a stent into the vessel at the center of my heart.He later explained i was "99% blocked and just a fraction away from having had very serious consequences".I am now attending cardiac rehab 2 days per week at the hospital (2hrs away, 4hrs driving time) and 3days week at home.Perhaps it is needless to say, but all of this has obviously created a severe hardship to me.I blame philips respironics for my health issues and wish they had somehow notified me years ago that i should have stopped using their defective cpap machine.They have caused me much pain and suffering, ongoing health issues, as well as expenses.Philips currently claims that only machines manufactured after 2009 are defective.I am here to say my cpap from pre-2009 made me severely ill and i am currently looking for someone to legally help me with restitution.Dates of use: (b)(6) 2000 - (b)(6) 2020.Reason for use: sleep apnea.The problem stopped after the person stopped using the product.(b)(6).
 
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Brand Name
REMSTAR AUTO
Type of Device
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
Manufacturer (Section D)
PHILIPS / RESPIRONICS, INC.
MDR Report Key13342407
MDR Text Key284465322
Report NumberMW5106919
Device Sequence Number1
Product Code BZD
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 12/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/24/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number1007381
Was Device Available for Evaluation? Yes
Patient Sequence Number1
Treatment
ALLOPURINOL ; ATORVASTATIN ; BABY ASPIRIN ; BRILINTA; LISINOPRIL; METOPROLOL ; OMEPRAZOLE; VENLAFAXINE
Patient Outcome(s) Hospitalization; Disability; Life Threatening; Required Intervention; Other;
Patient Age69 YR
Patient SexMale
Patient Weight98 KG
Patient EthnicityNon Hispanic
Patient RaceWhite
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