MAUDE Adverse Event Report: RESPIRONICS, INC. SYSTEM ONE 60 SERIES; 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	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.There was no report of serious or permanent harm or injury.There was no report of medical intervention.During the evaluation of the device, the third-party service center observed evidence of foam particles inside the blower kit.In addition, the device had dust/dirt contamination, fluid contamination, and displayed error code/ displayed error code e050 (err_daily_values_corrupt),error code e053 (err_comp_log_sem_timeout), error code e055 (err_therapy_queue_full), and error code e063 (err_stuck_knob_key).The device was scrapped as per customer request.

• Brand Name: 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: 23948048
• Report Number: 2518422-2026-000146
• Device Sequence Number: 18100295
• 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: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 01/02/2026

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: 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: 12/19/2025
• Initial Report FDA Received Date: 01/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/06/2012
• 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
• Usage of Device: Reuse
• 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