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

Model Number	CA461HS
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Asthma (1726); Cancer (3262); Unspecified Respiratory Problem (4464)
Date of Event	03/14/2023
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 an issue related to a cpap device's sound abatement foam became degraded and caused a 5 cm tumor in the left lung and increasing asthma symptoms.The patient did report to have had the tumor removed.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The manufacturer was previously 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 previously received information alleging an issue related to a cpap device's sound abatement foam became degraded and caused a 5 cm tumor in the left lung and increasing asthma symptoms.The patient did report to have had the tumor removed.The previous report was filed with patient outcome code grid (box h) being incorrect.In this report the following data are updated and corrected.
Additional Manufacturer Narrative
The manufacturer received new and relevant information on 08/06/2025.The device was returned to the service center for evaluation.During the evaluation of the device, the service center internally/ externally inspected the device and no foam particles had been observed.Additionally, the device was scrapped.Section g3 and h6 have been updated in this follow up report.

• Brand Name: REMSTAR PRO C-FLEX+
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): Respironics, Inc.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): Respironics, Inc.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: melissa rosko ; 1001 murry ridge lane; murrysville, PA 15668 ; +1(724)733-0200
• MDR Report Key: 16844937
• Report Number: 2518422-2023-10114
• Device Sequence Number: 6870485
• Product Code: BZD
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K131982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/03/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: CA461HS
• Device Catalogue Number: CA461HS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2023
• Supplement Date Received by Manufacturer: 03/14/2023; 08/06/2025; Not provided
• Initial Report FDA Received Date: 05/01/2023
• Supplement Report FDA Received Date: 04/25/2025; 11/04/2025; 09/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/25/2015
• 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: N
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RES 88058
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown