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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2026
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 evaluation of the device, the service technician observed blower foam degradation.Additionally, the service technician also noted a dust fail contamination and has a presence of error code e53 err_comp_log_sem_timeout, e80 err_unable_to_init_flow_sensor, and e93 rtc_value.The device was scrapped.This event is reportable under fda 21 cfr part 803 as it meets the criteria for a serious injury and/or product malfunction.

• 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: 24035265
• Report Number: 2518422-2026-001511
• Device Sequence Number: 9010835
• Product Code: BZD
• UDI-Device Identifier: 00606959014084
• UDI-Public: (01)00606959014084
• 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: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 01/12/2026

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: CA461HS
• Device Catalogue Number: CA461HS
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2026
• Initial Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/28/2014
• 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