MAUDE Adverse Event Report: PHILIPS RESPIRONICS, INC. PHILIPS RESPIRONICS AUTO CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DSX500H11

Device Problems Degraded (1153); Nonstandard Device (1420)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/14/2021

Event Type  Injury  

Event Description

(b)(6) 2019: diagnosed with sleep apnea syndrome.Jan 14, 2020: received respironics auto cpap dsx500h11; s/n; (b)(6) from health maintenance services, (b)(6).Jul 2021: received urgent letter from philips; stop using cpap due to "sound abatement foam susceptible to degradation and volatile organic emissions." i stopped using my cpap -- registered my name on recall list for replacement cpap.Jul 23, 2021: found cpap in-line filters on amazon which will block emissions from going to lungs -- placed order for 10 each.Started using cpap again with in-line filters -- after a few days noticed filter turning color from pure white to filthy dark gray -- started changing in-line filter every 15 to 18 days (as of this report date i ordered filters from amazon 6 times -- 10 each x 6 orders = 60 filters).Dec 2, 2022: received, due to recall, "reworked" cpap, respironics auto cpap dsx500h11; s/n: (b)(6).I continued using in-line filters -- this "reworked" cpap had same problem as the one i returned due to recall.It was turning filter dark gray in 15 to 18 days.Jun 4, 2022: i decided to let manufacturer (philips) know about my problem -- other users may unknowingly be damaging their lungs.I composed a letter of "complaint" explaining in detail my problem (with pictures of my clean and dirty in-line filters).I mailed 3 copies: (1) manufacturer: respironics; c/o; customer service; 1001 murry ridge lane; murrysville, pa 15668 (as of this date july 4, 2023, no reply from respironics) (2) pulmonologist: dr (b)(6), md; (b)(6) (3) cpap supplies: health maintenance services; (b)(6).(b)(6) 2023: i visited my cpap pulmonologist (dr.(b)(6)) in (b)(6); he recommended i get a "loaner" cpap and contact philips respironics to advise them of the problem.(b)(6) 2023: i went to health maintenance services, (b)(6), saw ms (b)(6) (owner) -- she loaned me a new never used cpap; respironics dreamstation dsx500h11; s/n: (b)(6) (with new inlet filters).We agreed that the new loaner is to be used by me as a test to see if the in-line filters change color with contaminants -- she is allowing me to use it until i get a satisfactory response from philips respironics.I started using the new cpap that night with all new filters.(b)(6) 2023: as of today, it is 21 days into my test, the in-line filter is barely showing a color change (nothing comparable to the 2 previous cpaps that needed in-line filter changed every 15 to 18 days).Out of concern for my lungs health, i will continue using in-line filters with whatever cpap device i may have.My health issues: obstructive sleep apnea syndrome, atrial fibrillation, essential hypertension, coronary arteriosclerosis, dyspena on exertion, spells of bronchitis, nebulizer treatment when needed.Reference report: mw5119184.

• Brand Name: PHILIPS RESPIRONICS AUTO CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS RESPIRONICS, INC.
• MDR Report Key: 17280794
• MDR Text Key: 318705115
• Report Number: MW5119185
• 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
• Report Date: 07/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX500H11
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White