MAUDE Adverse Event Report: RESPIRONICS, INC. REMSTAR SYSTEM ONE 60 SERIES; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	CA461S
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2025
Type of Reportable Event	Malfunction
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.A remstar pro c-flex+ device was returned to a third-party service center for evaluation of the device, with no initial alleged complaint.There was no death, serious harm, or injury reported, and no medical intervention was provided.During the evaluation of the device at the third-party service center, the device was visually inspected, and evidence of foam degradation/particles was found inside the blower kit.The device was found to have fluid contamination, the power connector was destroyed, and the unit was functional.In addition, the device displayed error codes e053 (timeout error), e031 (motor vbus high blow error), and e050 (daily values corrupt error), as recorded in the error log, which were not related to the foam degradation.The device was scrapped by the service center after the evaluation was completed.

• Brand Name: REMSTAR SYSTEM ONE 60 SERIES
• 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: 23925839
• Report Number: 2518422-2025-113432
• Device Sequence Number: 12989134
• Product Code: BZD
• UDI-Device Identifier: 00606959030145
• UDI-Public: (01)00606959030145
• 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: Other
• Initial Reporter Occupation: 505
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 12/30/2025

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: CA461S
• Device Catalogue Number: CA461S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/24/2014
• 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