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	09/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A remstar pro c-flex+ was returned to the service center in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.There was no initial alleged complaint found.During the evaluation of the device, the service technician observed visible foam particles inside the blower kit.Additionally, dust contamination was found during the evaluation.The service technician observed that certain error codes were present.The device was scrapped.There was no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.At this time, no further investigation can be performed.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: 23044275
• Report Number: 2518422-2025-110022
• Device Sequence Number: 15966033
• 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): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 09/12/2025

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: Other
• Device Model Number: CA461HS
• Device Catalogue Number: CA461HS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2025
• Initial Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/08/2012
• 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