MAUDE Adverse Event Report: Respironics, Inc. BIPAP AVAPS; Ventilator, Continuous, Non-Life-Supporting

Model Number	CA1161XTS
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A bipap avaps device was returned to the service center for evaluation.There was no initial alleged complaint found.During the evaluation conducted at the third-party service center, the device was visually inspected, and no evidence of foam particles was observed.Additionally, the service technician identified a burnt connector, and the device was forwarded to riql for further investigation.

• Brand Name: BIPAP AVAPS
• 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: 50015271
• Report Number: 2518422-2026-039698
• Device Sequence Number: 18786261
• Product Code: MNS
• UDI-Device Identifier: 00606959014060
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K102465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: 505
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2026

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: CA1161XTS
• Device Catalogue Number: CA1161XTS
• 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: 07/09/2026
• Supplement Date Received by Manufacturer: 07/29/2026
• Initial Report FDA Received Date: 07/27/2026
• Supplement Report FDA Received Date: 07/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/30/2014
• 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