MAUDE Adverse Event Report: RESPIRONICS, INC. BIPAP AUTOSV ADV; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	DS960TS
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer became aware of an event involving a bipap autosv adv device that was returned to a third-party service center for service as part of the sound abatement foam recall process.During evaluation of the device, the service technician observed a burnt humidifier connector.Additionally, unrelated to the reportable malfunction, dust contamination and a no-power condition were observed.No visible foam particles were identified during the inspection.Following completion of the evaluation, the device was scrapped by the service center.There was no report of death, serious injury, permanent impairment, or medical intervention associated with this event.Based on the identification of a burnt humidifier connector during device evaluation, this event was determined to be reportable under fda 21 cfr part 803 as a product malfunction and/or potential serious injury event.The device was forwarded for further investigation.No additional information is available at this time.A supplemental report will be submitted if significant new information becomes available.

• Brand Name: BIPAP AUTOSV ADV
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• 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: 25611299
• Report Number: 2518422-2026-025404
• Device Sequence Number: 12123604
• Product Code: BZD
• UDI-Device Identifier: 00606959012530
• UDI-Public: 00606959012530
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/24/2026

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: DS960TS
• Device Catalogue Number: DS960TS
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2026
• Initial Report FDA Received Date: 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/08/2015
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown