MAUDE Adverse Event Report: RESPIRONICS, INC. BIPAP AUTOSV ADVANCED SYSTEM ONE; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number	FR965S
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A device was returned to a third-party 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 third-party service center, the device was visually inspected/scrapped and found evidence of foam degradation.During the evaluation, foam particles were visible, and device was scrapped.

• Brand Name: BIPAP AUTOSV ADVANCED SYSTEM ONE
• Common Device Name: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• 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 ; 6501 living place; pittsburgh, PA ; 4125423300
• MDR Report Key: 22788773
• Report Number: 2518422-2025-108994
• Device Sequence Number: 8134280
• Product Code: MNS
• UDI-Device Identifier: 00606959029712
• UDI-Public: (01)00606959029712
• Combination Product (Y/N): N
• Initial Reporter Country: MB
• PMA/510(K) Number: K090539
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 08/12/2025

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: FR965S
• Device Catalogue Number: FR965S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2024
• Initial Report FDA Received Date: 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/05/2015
• 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-1658-2022
• Patient Sequence Number: 1
• Patient Sex: Unknown