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	12/23/2025
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 evaluation no foam particles were noted in the airpath, yet foam degradation was noted.The devices sound abatement foam (needs) or (was) replaced to address the issue.Also, a dust contamination was present on the device.There was no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.
Additional Manufacturer Narrative
A follow-up is necessary as the 510k under report information should be k131982 for remstar auto 60 series device.

• 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: 23956094
• Report Number: 2518422-2026-000202
• Device Sequence Number: 15814620
• Product Code: BZD
• UDI-Device Identifier: 00606959030060
• UDI-Public: (01)00606959030060
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2026

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: CA261HS
• Device Catalogue Number: CA261HS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 03/19/2026
• 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