MAUDE Adverse Event Report: RESPIRONICS, INC. REMSTAR PLUS W/HUM; 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	12/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A remstar plus w/hum device was returned to a third party service center for service as part of the sound abatement foam 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 was replaced to address the issue.In addition, the service center found contamination from dust fail, the device was scrapped by the service center after the evaluation was completed.This event is reportable under fda 21 cfr part 803 as it meets the criteria for a serious injury and/or product malfunction.

• Brand Name: REMSTAR PLUS W/HUM
• 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: 23936078
• Report Number: 2518422-2025-113585
• Device Sequence Number: 17549369
• Product Code: BZD
• UDI-Device Identifier: 00606959030060
• UDI-Public: (01)00606959030060
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K010263
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 12/31/2025

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: Lay User/Patient
• Device Model Number: CA261HS
• Device Catalogue Number: CA261HS
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 12/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/26/2013
• 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