MAUDE Adverse Event Report: RESPIRONICS, INC. BIPAP AUTOSV; VENTILATOR, 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	01/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A bipap autosv device was returned to a third party service center for service as part of the sound abatement foam recall process with no initial alleged complaint during evaluation of the device, the service technician observed visible foam particles inside the blower kit and blower foam degradation additionally, the service technician also noted a dust fail contamination and has a presence of error code e30 err_motor_spinup_flux_high, e66 err_stuck_encoder_b, e55 err_therapy_queue_full, e65 err_stuck_encoder_a, e63 err_stuck_knob_key, e21 err_motor_vbus_high, and e101 err_humig_temp_max.The device was scrapped.

• Brand Name: BIPAP AUTOSV
• Common Device Name: VENTILATOR, 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: 24056348
• Report Number: 2518422-2026-002016
• Device Sequence Number: 9348423
• Product Code: MNS
• UDI-Device Identifier: 00606959014237
• UDI-Public: (01)00606959014237
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K131982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 01/13/2026

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: Lay User/Patient
• Device Model Number: CA961TS
• Device Catalogue Number: CA961TS
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2016
• 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-1973-2021
• Patient Sequence Number: 1
• Patient Sex: Unknown