MAUDE Adverse Event Report: RESPIRONICS, INC. REMSTAR AUTOA-FLEX W/HUM; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	IN561HS
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2023
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 visualization of particles.No other clinical information or medical interventions were reported.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
On previously submitted report, section h11 was incorrect.It should be - the manufacturer previously reported was being 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 visualization of particles.The device was returned to third party service center and evaluated.Evaluation result stated that there are no visible foam particles.
Additional Manufacturer Narrative
The manufacturer previously reported was being 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 visualization of particles.The ventilator was evaluated by third party service center and evaluated.Evaluation result stated that there are no visible foam particles.

• Brand Name: REMSTAR AUTOA-FLEX W/HUM
• 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: 21460506
• Report Number: 2518422-2025-022234
• Device Sequence Number: 20781629
• Product Code: BZD
• UDI-Device Identifier: 00606959030763
• UDI-Public: (01)00606959030763
• Combination Product (Y/N): N
• 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: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/21/2025

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: IN561HS
• Device Catalogue Number: IN561HS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2023
• Supplement Date Received by Manufacturer: 08/06/2025; 11/21/2025
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 11/17/2025; 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/29/2016
• 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