MAUDE Adverse Event Report: RESPIRONICS, INC. REMSTAR PRO C-FLEX+; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	DS460TBT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dyspnea (1816); Memory Loss/Impairment (1958); Nausea (1970); Pulmonary Dysfunction (2019); Rash (2033); Vomiting (2144); Anxiety (2328); Confusion/ Disorientation (2553); Cough (4457); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); Upper Respiratory Tract Irritation (4872)
Date of Event	02/22/2022
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 that the reporter experienced multiple ongoing and severe health issues while using the philips cpap device, including lung and respiratory problems, waking up coughing and vomiting which led to hospitalization.Later the patient collapsed due to bronchospasms and was placed in a medically induced coma.In (b)(6) 2022, the reporter was hospitalized again with multiple health issues and was diagnosed with mast cell activation syndrome, causing severe nerve reactions and hypersensitivity.The reporter has developed severe allergies to a wide range of triggers, including animals and food.The reporter now carries several epipens at all times and cannot visit family members with pets due to risk of severe reactions.Eating and working have become difficult, resulting in significant weight loss and job loss (previously employed as a draftsperson).According to information presented after several years of using the device, the reporter experiences: tinnitus, poor memory, confusion, anxiety, cracked teeth, rashes, black eyes, wounds, palpitations, food allergies.Nausea, vomiting, skin, eye, nose respiratory tract irritation, shortness of breath, coughing, inflammation, etc.It is explicitly stated that a respiratory specialist linked the health issues to the cpap machines and that the device in use was confirmed to be defective.However, it is unclear how the issues to the cpap use were confirmed.The reporter requests that this report be included in the tga¿s statistics for future reference.The device has not yet been returned to the manufacturer for evaluation.If any additional information is received, a follow-up report will be filed.

• Brand Name: REMSTAR PRO C-FLEX+
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• 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 ; 1001 murry ridge lane; murrysville, PA ; 7247330200
• MDR Report Key: 23901540
• Report Number: 2518422-2025-113293
• Device Sequence Number: 13291092
• Product Code: BZD
• UDI-Device Identifier: 00606959030121
• UDI-Public: (01)00606959030121
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K131982
• 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
• Report Date (Section B): 12/27/2025

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
• Operator of Device: Lay User/Patient
• Device Model Number: DS460TBT
• Device Catalogue Number: DS460TBT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 12/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/18/2016
• 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
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1974-2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown