MAUDE Adverse Event Report: Respironics, Inc. BiPAP autoSV ADV; Ventilator, Continuous, Non-life-Supporting

Model Number	DS960XHS
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A bipap autosv adv device was returned to the service center for evaluation.There was no initial alleged complaint found.During the evaluation of the device at the third-party service center, the device was visually inspected and noticed the connecter was burned.Upon review of the reported event, the service center has been instructed to return the device to the product investigation lab (pil) for further investigation.

• Brand Name: BiPAP autoSV ADV
• 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 ; +1(724)733-0200
• MDR Report Key: 50009605
• Report Number: 2518422-2026-038447
• Device Sequence Number: 18326406
• Product Code: MNS
• UDI-Device Identifier: 00606959029798
• UDI-Public: (01)00606959029798
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• 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: Other,Company Representative
• Initial Reporter Occupation: 505
• Type of Report: Initial
• Report Date (Section B): 07/23/2026

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: DS960XHS
• Device Catalogue Number: DS960XHS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/24/2016
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown