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

Model Number	CA261HS
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A remstar plus device was returned to a third-party service center as part of the uno recall process with no initial alleged complaint.During the evaluation of the device, the service technician observed visible foam particles inside the blower kit.Additionally, the service technician noted dust fail contamination.The device was scrapped by the service center after the evaluation was completed.
Additional Manufacturer Narrative
In the previously submitted report, a remstar plus device was returned to a third-party service center as part of the uno recall process with no initial alleged complaint.During the evaluation of the device, the service technician observed visible foam particles inside the blower kit.Additionally, the service technician noted dust fail contamination.The device was scrapped by the service center after the evaluation was completed.In this report, updated event or problem description will be- 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 plus device was returned to a third-party service center with no initial alleged complaint.During the evaluation of the device at the third-party service center, the device was visually inspected, and evidence of foam particles was found inside the blower kit.Additionally, the service technician also noted dust fail contamination.The device was scrapped by the service center after the evaluation was completed.Box g 510k number has been updated or corrected in this report.

• Brand Name: REMSTAR PLUS
• 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: 24058584
• Report Number: 2518422-2026-002067
• Device Sequence Number: 9494674
• Product Code: BZD
• UDI-Device Identifier: 00606959030060
• UDI-Public: (01)00606959030060
• 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,Distributor
• Initial Reporter Occupation: 505
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2026

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: CA261HS
• Device Catalogue Number: CA261HS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2026
• Supplement Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/03/2015
• 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