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

Model Number	220P
Medical Device Problem Codes	Degraded (1153); Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2014
Type of Reportable Event	Malfunction
Event or Problem Description
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.The manufacturer received information alleging smoke coming out and filter was black.There was no allegation of serious or permanent harm or injury.No medical intervention was specified by the patient.The device was returned to the manufacturer's product investigation laboratory (pil) for investigation.An external and internal inspection of the device performed by qa during this investigation found no evidence of thermal damage or failure of the device.Qa also tested the device on the multi-function test station (mfts) and all tests passed as well.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.

• Brand Name: REMSTAR SE ASSY
• 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 ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 22462764
• Report Number: 2518422-2025-047962
• Device Sequence Number: 9231730
• Product Code: BZD
• UDI-Device Identifier: 00606959038356
• UDI-Public: (01)00606959038356
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K131982
• Number of Events Summarized: 1
• Summary Report (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): 07/09/2025

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: 220P
• Device Catalogue Number: 220P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2014
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2014
• Initial Report FDA Received Date: 07/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2014
• 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: Female