MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION BIPAP AUTOSV; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number	DSX900T11C
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Dyspnea (1816); Myocardial Infarction (1969); Loss of Vision (2139); Coma (2417); Low Oxygen Saturation (2477); Nodule (4551); Sleepiness/Drowsiness/Somnolence (4850)
Date of Event	08/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer was contacted in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer received information alleging visualization of particles in the air path.The manufacturer received information alleging the patient was hospitalized for 10 days and was not able to breathe.It is unknown why the patient had a hard time breathing.The patient reports having low oxygen and couldn't sleep because of the sleep apnea.The patient reports driving off the road due to falling asleep.The patient reports nodules on lungs, had two heart attacks with one massive heart attack occurring two years ago.Due to this, the patient went into a coma.The patient reports they lost eyesight in their right eye.The patient's white blood cell count is now 11 and has cancer.The allegation of cancer was captured in report 2518422-2024-29095 that was previously submitted.The patient reported using an ozone based disinfection device 4 or 5 years ago for 2 or 3 months.The patient believes the device is quietly killing him.The patient reports they had five philips devices and has two devices now.One device was sent back to persante, one he believes he threw away and he does not know who has the third one.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
During internal review, it was determined that a duplicate report was previously submitted for this event under mfr 2518422-2024-101196.That submission was entered in error and should not be considered a separate or additional event.The current report mfr 2518422-2021-04191 reflects the accurate and intended submission for this complaint.No new information or new incident occurred; this correction is to clarify and remove the unintended duplicate report.

• Brand Name: DREAMSTATION BIPAP AUTOSV
• Common Device Name: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer Contact: melissa rosko ; 6501 living place; pittsburgh, PA ; 4125423300
• MDR Report Key: 20328025
• Report Number: 2518422-2024-101196
• Device Sequence Number: 7782763
• Product Code: MNS
• UDI-Device Identifier: 00606959045385
• UDI-Public: 00606959045385
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K090539
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: DSX900T11C
• Device Catalogue Number: DSX900T11C
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/27/2024
• Supplement Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/20/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1973-2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Male