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

Model Number	IN261S
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Unspecified Heart Problem (4454)
Date of Event	03/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 other text : device not returned to manufacturer.
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 patient alleges anomalies following a pulmonary visit due to the use of the device.No medical intervention was required by the patient.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
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 patient previously alleges anomalies following a pulmonary visit due to the use of the device.No medical intervention was required by the patient.Despite multiple attempts for device return, the device has not yet returned to the manufacturer for evaluation.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.The material number has been updated.Device evaluation method code, result code and conclusion codes has been updated in this report.

• Brand Name: REMSTAR PLUS
• 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: 17905721
• Report Number: 2518422-2023-26140
• Device Sequence Number: 15339308
• Product Code: BZD
• UDI-Device Identifier: 00606959028654
• UDI-Public: 00606959028654
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Followup
• Report Date (Section B): 12/02/2025

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: IN261S
• Device Catalogue Number: IN261S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2023
• Supplement Date Received by Manufacturer: 06/27/2024
• Initial Report FDA Received Date: 10/10/2023
• Supplement Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/04/2014
• 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