MAUDE Adverse Event Report: PHILIPS/RESPIRONICS, INC. PHILIPS RESPIRONICS BI-PAP AUTO SV; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number 1038917

Patient Problems Dyspnea (1816); Fatigue (1849); Headache (1880); Pain (1994); Rash (2033); Urinary Tract Infection (2120); Sore Throat (2396); Cough (4457); Unspecified Respiratory Problem (4464)

Event Type  malfunction  

Event Description

Used philips respironics bi-pap auto sv from (b)(6) 2009, until it stopped working properly in 2017 (would not consistently turn on or off (suspecting a bad pad under the power button, or some other electrical issue)), i requested that my pcp (primary care provider) order a new machine.Once the new c-pap (continuous positive airway pressure) was received, i sealed up the respironics bi-pap and stored it.I received the 2021 recall, but the specific reason was not clarified; mentioned device replacement, so i presumed that this was a mechanical issue.I could not locate my dysfunctional respironics bi-pap, and since i had a new replacement machine, did not search for my old machine to send it back for the recall.On or about february 21, 2024, i located my recalled respironics bi-pap; i searched online to see whether i could still return it to respironics.This is how/when i learned of the pe-pur foam degradation, which concerned me, since i have been experiencing recurring respiratory issues, since prior to 2017.These started with a recurring non-productive cough, with misty chest congestion, tight chest making it hard to inhale adequately, fatigue and various stiffness and "viral" symptoms).In retrospect, i also recalled one incident, prior to 2017, where i awoke while using my bi-pap and noticed a foreign particle on the back area of my tongue.My reflex reaction was that this was a bug, so i swiftly brushed it out of my mouth; it felt more like a bread crumb.My recent awareness of the pe-pur foam degradation and potential particle ingestion through the mask, coupled with my persistent, unresolved respiratory symptoms, has prompted me to complete this report; in the event that testing may confirm that the pe-pur foam in my bi-pap (which i used for over 8 years), can be attributed to my, now, chronic respiratory symptoms.The persistent, recurring cough began sometime prior to 2017.My pcp at that time, ordered chest x-ray (normal), and some medications were ceased (noted as allergic reactions).This chest tightness/shortness of breath with misty congestion, et al., seemed to recur at 2-3 month intervals.When covid hit in early 2020, my employer ((b)(6)) required symptom screening/daily reporting, which also resulted in about seven negative covid swab tests, over the next couple of years.Since i worked 100% remotely, i stopped reporting these recurring respiratory symptoms as rigorously, since they were now, not new symptoms to me.My current pcp, ordered another chest x-ray in 2022, due to sounds he noticed in lower left lung base.Again x-ray was normal.In 2022, i began experiencing wild, unexplained histamine reactions (rashes, swelling of hands, insect bites swelling like tennis balls, hypersensitivity to scents), along with the recurring respiratory/chest cough symptoms.Tested negative for celiac disease, and common food allergies (mild peanut reaction).I have noticed that these respiratory/chest symptoms can often accompany frequent utis (urinary tract infections) that i have experienced for years.On (b)(6) 2024, i tested positive for a major uti, and also reported the chest tightness, misty cough, and shortness of breath that i was concurrently experiencing.Rsv (respiratory syncytial virus) swab, flu swab, and another covid swab were thankfully negative.I completed 7 days of 500mg cipro (2x daily); am still experiencing residual chest tightness/shortness of breath (which leads to hyperventilation), misty chest cough, and fatigue.The neck stiffness and other back pains/aches appear improved after completing all antibiotics.Recorded history of symptoms with my sleep apnea doctor.Am scheduled for a spirometry test and chest x-ray next week.Due to the length of time that i have experienced these seemingly progressive respiratory symptoms (over eight years), and the overlap of their initial presentation with my respironics bi-pap use, i hope an unbiased lab will test the foam, and filter.Photos, showing areas of foam degradation, blackened mask filter, and crumbling debris particles are available.Two normal chest x-rays between 2017 and 2022; pending chest x-ray and spirometry lung function test scheduled on (b)(6) 2024.Respiratory symptoms began prior to 2017; sore throat, dry cough, chest tightness/pressure with shortness of breath (occasional hyperventilation, due to limited sense of vital capacity), misty chest congestion, achiness with feeling flushed, stiffness, headache (not responsive to my migraine treatment; emgality and nurtec), severe fatigue.Negative celiac disease tests, and minimal reaction to food allergy screening (mild peanuts).Photos of foam degradation and crumbling debris; mask degradation and blackened plastic portals, through which tubing air flows (also note the crumbled foam debris in background), are attached below; photos available upon request; bi-pap auto sv device (serial number (b)(6)), volume and size of foam debris that crumbles with gentle disturbance, and condition of filter; after 7+ years sealed in storage; ambient air, residual moisture from humidifier use, and possible particle/gas breakdown of pe-pur foam) bi-pap auto sv, serial number: (b)(6), product# 1038917.(negligible due to faded carbon copy receipt from 2009).

• Brand Name: PHILIPS RESPIRONICS BI-PAP AUTO SV
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): PHILIPS/RESPIRONICS, INC.
• MDR Report Key: 18884937
• MDR Text Key: 337524894
• Report Number: MW5152599
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial

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: Lay User/Patient
• Device Model Number: 1038917
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/08/2024
• Patient Sequence Number: 1
• Treatment: ATORVASTATIN.; CALCIUM .; DEXAMETHASONE INJECTIONS.; EMGALITY INJECTION.; FAMOTIDINE.; MAGNESIUM GLYCINATE.; METFORMIN.; METHENAMINE.; METOPROLOL.; MODAFINIL.; MULTI VITAMIN WITH OMEGA.; NURTEC ODT.; OZEMPIC 1GM.; QUNOL ULTRA CO-Q10.; RESMED CPAP.; VITAMIN C.; ZINC D.
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White