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

Model Number	CN257HS
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A remstar plus c-flex device was returned to a third-party service center for service as part of the sound abatement foam recall process.During the evaluation of the device, the service technician observed visible foam particles inside the blower kit.Additionally, the device was routed as scrapped.This event is reportable under fda 21 cfr part 803 as it meets the criteria for a serious injury and/or product malfunction.
Additional Manufacturer Narrative
This report is being sent to correct our previous submission.The bad was updated to (b)(6) 2024.

• Brand Name: REMSTAR PLUS C-FLEX
• 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: 24563608
• Report Number: 2518422-2026-009060
• Device Sequence Number: 21187755
• Product Code: BZD
• UDI-Device Identifier: 00606959001022
• UDI-Public: (01)00606959001022
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Distributor
• Initial Reporter Occupation: 505
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2026

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: CN257HS
• Device Catalogue Number: CN257HS
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/10/2026
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/27/2015
• 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