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

Model Number	1056210
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being submitted as part of a batch submission of complaints deemed reportable following record correction and remediation efforts.
Event or Problem Description
A device was returned to a manufacturer's service center in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.During the evaluation of the device at the manufacturer's service center, the device was visually inspected and found evidence of foam.During the evaluation, the device powered on and airflow was confirmed.The device's downloaded logs were reviewed by the manufacturer's service center.There were 32 error codes found.The manufacturer's service center concludes that there were visible foam degradation and unit got scrapped.

• Brand Name: SYSTEM ONE REMSTAR HEATED
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: melissa rosko ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 23670199
• Report Number: 2518422-2025-058464
• Device Sequence Number: 18603457
• Product Code: BZD
• UDI-Device Identifier: 00606959002210
• UDI-Public: (01)00606959002210
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K131982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 11/28/2025

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: Other
• Device Model Number: 1056210
• Device Catalogue Number: 1056210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2023
• Initial Report FDA Received Date: 11/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2014
• 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