MAUDE Adverse Event Report: RESPIRONICS, INC. REMSTARPROCFLEX; VENTILATOR NON-CONTINUOUS (RESPIRATOR)

Model Number	CA461NTS
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A remstar pro c flex device was returned to a third party service center for service as part of the sound abatement foam recall process with no initial alleged complaint during the evaluation of the device, the service technician observed visible foam particles inside the blower kit and object code indicates the blower contributed to the foam degradation.Additionally, the service technician noted dust fail contamination.The evaluation of the device data identified unrelated error codes.These error codes are consistent with normal device operation and expected use conditions and are not considered reportable under medical device reporting requirements.No evidence was identified to suggest that these error codes contributed to or caused the reported event.The device was scrapped by the service center after the evaluation was completed.
Additional Manufacturer Narrative
Updated the conclusion code.

• Brand Name: REMSTARPROCFLEX
• 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: 24271844
• Report Number: 2518422-2026-004217
• Device Sequence Number: 10621486
• Product Code: BZD
• UDI-Device Identifier: 00606959030152
• UDI-Public: (01)00606959030152
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2026

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
• Operator of Device: Lay User/Patient
• Device Model Number: CA461NTS
• Device Catalogue Number: CA461NTS
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/29/2015
• 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
• 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
• Patient Sex: Unknown