MAUDE Adverse Event Report: RESPIRONICS, INC. BIPAP AUTOSV ADVANCED SYSTEM ONE 60 SERIES; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number	CA961TS
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2025
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 device was returned to a third-party service center for evaluation.During the evaluation of the device, the third-party service center visually inspected the device and found evidence of visible foam particles or degradation inside the blower kit.Additionally, the service technician also noted error code e024(err_sensor_flow_offset_stop).The device was scrapped by the service center after the evaluation was completed.
Additional Manufacturer Narrative
The manufacturer was previously 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 device was returned to a third-party service center for evaluation.During the evaluation of the device, the third-party service center visually inspected the device and found evidence of visible foam particles or degradation inside the blower kit.Additionally, the service technician also noted error code e024(err_sensor_flow_offset_stop).The device was scrapped by the service center after the evaluation was completed.In the previous report operator of the device, occupation, report source, reason device not evaluated, health impact code was not updated correctly, which have been updated in this report, box d, e, g, h have been updated/corrected.

• Brand Name: BIPAP AUTOSV ADVANCED SYSTEM ONE 60 SERIES
• 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 ; 1001 murry ridge lane; murrysville, PA ; 7247330200
• MDR Report Key: 24008646
• Report Number: 2518422-2026-001183
• Device Sequence Number: 18493225
• Product Code: MNS
• UDI-Device Identifier: 00606959014237
• UDI-Public: (01)00606959014237
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K090539
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: 505
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2026

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: CA961TS
• Device Catalogue Number: CA961TS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2025
• Supplement Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/26/2015
• 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-1973-2021
• Patient Sequence Number: 1
• Patient Sex: Unknown